Working at Aptalis

Employment Opportunities in Canada

Project Engineer, Technical Services
Tue, 21 May 2013 20:45:57 GMT

Reporting to the Senior Project Manager, Technical Services, the Project Engineer, Technical Services, is responsible for writing, planning, first pass analysis and data gathering of key qualification/validation documents. The incumbent is mostly responsible for project management activities and quality documents related to equipment and processes. The Project Engineer supports the Senior Project Manager, Technical Services and the Manager, Building and Engineering in their company strategic projects. These include batch size reduction or increase, process or equipment improvements or optimization, new API qualification, new equipment installation, etc. The Project Engineer will also support the Senior Project Manager, Technical Services with regards to validation and qualification projects related to outsourced products manufactured by contract manufacturing organizations (CMO) .   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Responsible for project management of multiple equipment qualification and process validation projects with multidisciplinary teams; Ensures detailed tracking of the project progression using project management tools such as: action logs, projects charters and Gantt charts; Coordinates qualification and validation activities of multi-functional teams; Ensures adequate communication between various teams and various team members ( Materials Management, Manufacturing, Engineering, Quality Assurance and Regulatory Affairs) ; Writes process validation and equipment qualification protocols and reports (IQ, OQ, PQ, …); Participates to the equipment supplier selection process and responsible for the creation of technical engineering documents pertaining to the equipment selection process (RFQ, URS); Prepares project related quality documentation (change control, deviations, SOP, …) as well as technical analysis and memos if required; Provides technical input and acumen pertaining to projects as well as process and equipment potential improvements; Responsible to maintain the validation/qualification documentation up to date and in an orderly manner (paper based documents as well as electronic versions); Executes validation, qualification and engineering protocols according to good documentation practices; Updates the revalidation and requalification assessments of the site equipment and processes on a regular basis and track validation status; Provides project management help for some major building related projects; Participates to continuous improvements projects within multidisciplinary teams; Attends various departmental meetings; Attends work on a regular and predictable basis; Completes assigned tasks in a safe manner and in a constant state of alertness; Upholds all Company policies, including but not limited to, the Aptalis Code of Conduct and the Professional Conduct Policy and Prohibition Against Harassment Policy; Works in a cooperative manner with managers, supervisors, coworkers, customers and the public; Supports the Aptalis vision and mission and exemplifies Aptalis values.   SUPERVISORY RESPONSIBILITY Non applicable.   REQUIREMENTS Bachelor’s Degree in Chemical/Mechanical/Biochemical Engineering, or in a related engineering field combined to a minimum of 3 to 5 years experience, including experience in the pharmaceutical industry. Working knowledge of US and/or Canadian cGMP Acute planning and multitasking skills Ability to perform under pressure Excellent written and spoken (French and English) communication skills Sound technical expertise Problem identification and solving capabilities (troubleshooting) Detailed oriented Hands-on (ability to execute protocol, document results, compile experimental data, …) Proactive and result oriented Good leadership and interpersonal skills Ability to work as part of multi-functional teams Proficient in Microsoft Office tools (MS project an asset) Some project management expertise PMP certification an asset

Buyer, Goods and Services (6 month contract)
Tue, 07 May 2013 18:52:49 GMT

The primary duties and responsibilities of this position include the following.  Other duties may be assigned.   Reporting to the Director, Global Sourcing the incumbent is responsible for assisting divisional colleagues (internal customers) and the Director, Strategic Sourcing,  in the procurement of goods and services in full compliance with Aptalis procurement policies. He or she places and expedites SAP purchase orders, resolves associated problems, and participates in internal sourcing projects as assigned. He or she identifies suppliers for goods and services in collaboration with sourcing managers, and supports the supplier evaluation program. He or she participates in the strategic activities of spending analysis, and supplier selection for partnership development. He or she provides support, guidance and training to SAP users with issues related to procurement. RESPONSIBILITIES Provides high quality customer service to internal customers. Serves as an advisor to all client groups by explaining the advantages and disadvantages associated with different purchase options including comparison of supply sources. Expedites outstanding orders on a timely basis to meet customer needs. Contacts or responds to internal customers to clarify or provide information as necessary, such as to obtain acceptable substitute product/service or sourcing information. Supports the Director, Global Sourcing to implement sourcing strategies. EConducts strategic sourcing activity (requests for information (RFI), requests for quotation (RFQ), requests for purchase (RFP), contracting with suppliers, etc.) with the support and guidance of the Director, Global Sourcing as needed. Reviews requisitions prepared by internal customer, review specifications, supplier selection, quantity and quality of product or service to ensure that orders are placed with suppliers in a timely manner. Identifies missing or incorrect data/information to complete a PO, and places non-catalog orders. Follows up with internal customer and/or suppliers to complete order as necessary. Escalates quality or service issues with appropriate person. Provides reports as required. Monitors SAP usage KPIs for sourcing. Participates in internal SAP user group meetings and special projects, such as internal functional committees, as assigned.   REQUIREMENTS   Bachelor’s degree in Business Administration, or equivalent, combined with 3 years of purchasing experience (purchasing ethics, competitive bids process, etc...) in the pharmaceutical industry. Education in Purchasing and/or Purchasing training on specific subjects during professional life, commodity specific knowledge (to better assess the validity of the P.O. content) an asset. Good understanding and knowledge of financial policies, including procurement policy, regulations/tax issues purchasing-related, and custom clearance will be required. Ability to process purchasing requests, supporting internal customers (customer focus), and keeping 100% compliance to policies. Ability to understand situations; ease of expression, simplicity, clarity and concision both orally and in writing; ability to convince, create consensus and momentum. Demonstrated abilities in negotiation. Ability to organize and manage activities in an orderly manner, in order to avoid scattered and irrelevant results. Ability to effectively manage multiple purchasing requests of varying complexity and adhere to tight timelines. Ability to collect quantitative or qualitative information from different sources, set it out in a logical sequence, and identify underlying issues and trends. Ability to work effectively in team environment. Keep a positive attitude. Systems and internet IT savvy. Fluency in French and English is required. Some travel may be required.

Clerk, Production & Packaging
Tue, 23 Apr 2013 18:05:11 GMT

Reporting to the Manager, Manufacturing, the incumbent’s main responsibilities are to perform various steps in manufacturing and packaging products. RESPONSIBILITIES Cleans white rooms, following established procedures. Prepares and sets up packaging equipment. Weighs raw materials. Manufactures and packages products in accordance with master files and procedures while assuring product quality. Supplies and monitors equipment in production. Fills in master files and forms for each instruction followed for each batch produced and/or procedure performed. Keeps up with current standard operating procedures (SOP) by taking part in continuing education program. Follows good manufacturing practices (GMPs) and standard operating procedures (SOPs) in performing duties. Cleans equipment used after each packaging run, following established procedures. Performs any other job-related task. Acts as Company representative by showing respect for Company’s established values. Helps develop and implement methods, procedures and regulations necessary for department’s smooth operation. Follows Company policies, procedures and regulations. REQUIREMENTS High school diploma (DES), with two years’ experience in production. Pharmaceutical, cosmetic or food manufacturing industry represents an important asset. Attention to quality. Ability to do teamwork. Logical skills. Ability to do physical work. Ability to lift up to 25 kg. Familiarity with GMPs. Analytical skills and problem solving. Through familiarity with production and handling safety principles. Maintenance of confidentiality in all facets of work.

Senior Analyst, Financial Planning & Analysis – Global Supply Chain (12 month contract)
Fri, 05 Apr 2013 20:05:30 GMT

Reporting to the Manager, Financial Planning & Analysis the incumbent is responsible for the cost accounting system maintenance and analysis related. Also responsible for supporting department managers in the decision making related to the financial aspects of the Manufacturing and Quality department. Participates in the development of the annual planning and contributes to upholding the financial health.   RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned.   Calculates the cost of product for the SP business segment at item creation, in the budget process and for business development purposes. Explains variances on a monthly basis. Participates in the preparation of indicators that allow performance measurement of the operations. Follows-up on relevant performance indicators and pre-identified targets. Collaborates with department managers during the preparation of the strategic plan. Actively participates in the preparation of the annual plan (budget), in the preparation of appropriate cost drivers, and in the budgetary control.  Carries out the monthly analysis of the budget variances. Participates in the preparation of the quarterly and revised annual forecasts (LBE). Develops and prepares relevant management reports in order to meet the needs of the Manufacturing, Sourcing and Quality department managers. Prepares various communications presented to department’s managers. Works with the Manufacturing, Sourcing and Quality department managers in order to identify improvement opportunities related to the financial management of their projects. Stays up-to-date on the best practices in order to best advise the clients. Develops and maintains relationships within the financial services and with other departments in order to ensure optimal exchange of information. Supports the financial services with different demands of analysis related to the Manufacturing, Sourcing and Quality department.   REQUIREMENTS            University degree in accounting or the equivalent together with a minimum of five (7) years of relevant experience that includes experience in a manufacturing company as cost accountant. Holder of a relevant professional accounting title. Experience in a pharmaceutical company is required. Capacity to lead project and address issues autonomously. Cost accounting knowledge and experience. Cost saving project tracking experiences Abilities in communication and interpersonal relations with internal clients and external partners / stakeholders. Ability in advising managers and influencing the decisions within his department. Abilities in project management. Quality in planning and work organization. Respect of confidentiality in all aspects of work. Capacity for synthesizing and analyzing. Ability to work under pressure. Good knowledge of operation of an accounting program (AX and/or SAP is an asset). Good knowledge of operation of Cognos TM1. Good knowledge of generally accepted accounting principles. Quality of judgement and evaluation of situations. Business sense. Ability to adapt in a fast-changing environment. Proficiency in Microsoft Office suite. Excellent oral and written skills both in English and French, Italian is an asset.

Senior Director, Financial Compliance
Mon, 17 Dec 2012 16:11:20 GMT

  Reporting to the Senior Vice President, Chief Financial Officer and Treasurer with a dotted line to the Audit Committee, the Senior Director, Financial Compliance will assist management and the Audit Committee by providing independent, objective assurance services pertaining to internal controls, safeguarding of assets, adherence to policies including related governance and advisory services intended to improve Aptalis operations. This position will also be responsible for the development, implementation, performance, supervision and reporting on the adequacy of the Company’s system of internal controls over financial reporting as well as managing the external audit function. In addition, the Senior Director, Financial Compliance will be responsible for reviewing processes and controls, and overseeing operational audits to improve processes throughout all aspects of the business . This position will also manage internal resources as well as third-party service providers as required.   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Internal Audit Performs, reviews and/or manages various types of audit engagements (including Operational, Compliance, Financial, Information Systems, and Investigative Audits) and advisory engagements, or special projects as directed by Senior Executive(s). Assesses risk factors to identify all areas of risk within the organization. Performs the value for money by managing studies on the effectiveness of our processes. Determines and recommends internal audit policies and standards and directs their implementation. Develops and implements the Global 3-year audit plan. Coordinates with the Compliance Department to perform cross-department integrated audits. Plans, directs and controls internal audit operations in order to attain the Company’s strategic and functional objectives. Provides, following an internal audit, advice to the Management Team in their respective areas of activities and collects their comments on the conclusions and recommendations included in internal audit reports. Submits internal audit reports to executive management and the Company’s Audit Committee. Audits accounting data within the Company’s subsidiaries or departments. Analyses operational, accounting and administrative systems, as well as procedures’ deviations, for the Company’s business activities. Analyses and audit’s the Company’s information technology governance processes as well as the Company’s systems. Benchmarks key business processes in order to identify solutions to increase corporate performance and efficiency. Prepares reports regarding audit results and submits recommendations on corrective measures implementation, including procedures, policies and practices.   Financial Compliance Program Evaluates internal control design for various projects of the Company’s business units, identifies gaps and proposes solutions. Directs internal control SoX testing on a quarterly basis. Prepares the annual Sarbanes-Oxley (SoX) Planning and Scoping assessment. Manages the external audit function. Advises senior management on the design of corporate governance control procedures. Analyses the Company’s disclosure controls and procedures. Ensures processes are in place in compliance with Sunshine Act and performs control testing. Designs and optimizes process workflows to be used across the team to improve system uptime, customer satisfaction and decrease reactive work taken on by the team.     Global Policies Acts as a facilitator to other business units and assists in the development and implementation of best practices throughout the organization. Identifies and communicates changes in applicable professional standards, pronouncements, laws, guidelines and audit requirements. Serves as the expert global financial policy advisor and ensures the company follows and applies those policies within the organization.   Other Supervises the activities related to financial compliance. Hires, assigns , develops and supervises employees under his supervision.    REQUIREMENTS            Bachelor in Finance or Accounting or equivalent as well as an accounting title (CPA, CA, CMA, CGA), combined with a minimum of seven to ten (7-10) years of internal or external audit experience and project management experience including five (5) years supervisory experience.  Certification in internal auditing, IT audit and/or IT security would be considered an asset (CIA, CISA or CISSP). Experience in the pharmaceutical industry is also an asset. Excellent written and oral communication skills with the Company’s various internal and external stakeholders. Excellent interpersonal relationships skills. Quality of planning and organization of work load. Ability to plan and manage several projects and responsibilities simultaneously. Respect of confidentiality in all aspects of the job. Capacity for synthesizing and analyzing. Ability to work under pressure. Good knowledge in the operation of an accounting software (SAP and AX is a plus). Excellent knowledge of the generally accepted accounting principles of the United States. Quality of judgment and of evaluation of situations. Business sense. Facility to adapt to a fast changing environment. Proficient in use of Microsoft Office. Ability to identify and solving problems. Decision-making skills. Detail oriented. Excellent command of the English and French languages both written and spoken, Italian would be an asset. Ability to accommodate up to 35% to 40% travel.

Employment Opportunities in the United States

Operator 1
Wed, 22 May 2013 20:45:11 GMT

OPERATOR 1 This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions. The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following. Other duties may be assigned. • Learning to disassemble, clean and reassemble production equipment to prepare for processing. • Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. • Learning to operate the process equipment to create product that meets pre-determined specifications. • Learning to monitor and record critical process parameters. Learning to make necessary adjustments to assure finished product meets customer specifications. • Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. • Learning to package finished product and transfer to warehouse. • Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. • Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. • Responsible for keeping work area neat and orderly along with observing all safety procedures. • Follows other job-related instructions and performs other job-related duties as requested. • Adheres to cGMP guidelines as well as the CFR. • Attends work on a regular and predictable basis. • Completes assigned tasks in a safe manner and in a constant state of alertness. • Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. • Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. • Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy. Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Ability to perform mathematical calculations. • 1 + years experience in manufacturing environment. • Must be able to read and understand written instructions. • Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1. Physical Demands: The employee is required to: • stand, walk, push, pull, twist, reach overhead, and bend to the floor • occasionally move items or equipment weighing up to 100 pounds • occasionally required to climb ladders and/or steps to reach equipment 2. Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope. 3. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6. Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical. Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: • Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. • Receives direct supervision and works mainly with a trainer or higher level operator. • Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position. While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Manager Marketing - Pharmaceutical Technology
Wed, 22 May 2013 19:46:27 GMT

MARKETING MANAGER, PHARMACEUTICAL TECHNOLOGIES JOB SUMMARY: The purpose of the Marketing Manager is to evaluate the Pharmaceutical Technologies business in support of the global Business Development and Licensing team objectives, identify issues and opportunities within the business , create and develop marketing programs to address these opportunities and implement aligned tactics. The Marketing Manager will interact with the commercial team located in a number of Aptalis offices in the US and Europe; specifically members of Business Development, Licensing, Sales, Operations and R&D functions. Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. • Manages multiple projects • Plans and develops tactics aligned with predefined strategies and establishes timelines and budgets for them • Gives input on strategy and direction of the brand • Identifies and pursues opportunities to drive business growth.  Identifies obstacles to business growth; works collaboratively to resolve them • Manages overall and specific budgets and resources to achieve defined targets • Monitors and evaluates competitive products and marketplace dynamics. Analyze   market data and information • Develops marketing materials and obtains approval through the appropriate committees.  Works closely with BD and Licensing teams to ensure implementation. • Works with agency partners to create, develop and implement tactical plans to meet   defined timelines • Develop conference strategy and oversee execution to achieve defined targets. • Makes presentations to internal functions and management in various meetings GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • BA/BS degree in Science or Business  (MS in Marketing or MBA preferred) • Minimum 5 years industry, and minimum 2 years marketing management experience • Computer / Microsoft office proficiency required • Proficiency in managing and directing agencies and vendors • Managing and working within budgets QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The Marketing Manager will interact with the commercial team located in a number of Aptalis offices in the US and Europe; specifically members of Business Development, Licensing, Sales, Operations and R&D functions. The successful candidate will be proficient in the following interpersonal skills: • Ability to work with a high degree of independence and self-initiative • Possesses high degree of self-confidence, intellectual curiosity, and positive attitude • Effectively prioritizes and spends time and time of others on critical topics and effectively adjusts plan of action as needs change • Proven ability to manage multiple tasks concurrently under aggressive timelines in a   dynamic environment. • Comfortable working across functional areas; team player who can work well with   international cultures and diversity • Superior oral, written and presentation skills with comfort in communicating to all levels of management

Manufacturing Intern
Wed, 22 May 2013 19:24:06 GMT

Manufacturing Intern JOB SUMMARY   This intern will work with the plant operations team to perform activities involving data collection, time studies, preparing data for analysis of current operations performance and other duties, as assigned .   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Monitor and collect operation cycle times Collect downtime data and root cause information Enter all data into existing database or electronic form to be developed Review batch records and extract necessary information for analysis Assist with evaluating the data for accuracy and completeness Observe operator activities and assist in updating standard work documentation Attends work on a regular and predictable basis. Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds all Company policies, including but not limited to, the Aptalis Code of Conduct and the Professional Conduct Policy and Prohibition Against Harassment Policy. Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. Supports the Aptalis vision and mission and exemplifies Aptalis values.     SUPERVISORY RESPONSIBILITY None   EDUCATION AND/OR EXPERIENCE  Must be working to obtain a College Degree preferably in Industrial Engineering.  Other engineering, business or supply chain majors will be strongly considered. Previous work in a manufacturing environment is a plus. QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Excellent interpersonal written and oral communication skills Experienced with Microsoft Office including intermediate skills in Excel (Formulas, etc.). Ability to coordinate, contribute to and work within a cross-functional team. Ability to thrive in a dynamic and fast-paced environment. Able to prioritize duties and manage multiple projects from start to finish with minimal supervision. Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. Exceptional attention to detail and excellent organizational skills.   COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).   Aptalis Pharma is an Equal Opportunity Employer    

Category Manager, Direct Materials and Services
Wed, 22 May 2013 16:10:51 GMT

CATEGORY MANAGER, DIRECT MATERIALS AND SERVICES JOB SUMMARY The individual will be accountable for developing a category plan as it relates to the procurement of direct materials and services (Raw Materials, Intermediates, APIs, and Finished Goods). Re-sponsible for developing Requests for Information (RFIs), Requests for Quotations (RFQs), Re-quests for Proposals (RFPs) and sourcing plans for direct materials and services. Manages the supplier selection process working collaboratively with a cross-functional team. Experience with contract negotiations and the execution of supply agreements is critical for success in this role. Reviews supplier performance and leads periodic supplier business reviews. Proactively supports the materials management team to ensure continuity of supply. Initiates and/or participates in projects that will drive sustained productivity and operational efficiency. Helps identify new sources of supply and evaluates costs and supplier capabilities. Partners with various Research, Commercial, and Supply Chain contacts to develop forward looking sourcing strategies that enable corporate business objectives and effectively manage total cost of ownership to Aptalis.  The individual will also be required to apply best in class Supplier Relationship Management practices. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following. Other duties may be assigned. •  Define Direct Material and Services category strategy to support establishing sources of supply, maximizing current and future market conditions, and ensuring continuity of supply through contingency plans •  Partner with R&D, Brand and Supply Chain leaders to develop forward-looking sourcing strategies for direct materials and services •  Lead the strategic sourcing process for direct material sourcing events •  Develop and negotiate performance-based supply agreements and related contracts •  Define and track supplier performance metrics •  Lead periodic business reviews with key suppliers •  Identify new sources and evaluates suppliers’ capabilities •  Support all Research and Development efforts relating to suppliers as required •  Support all product launches as required to ensure supplier-facing deliverables are met •  Interface directly with Finance to fully and accurately document cost savings •  Partner with the Aptalis 3rd Party Manufacturing team to negotiate agreements with Contract Manufacturing Organizations (CMOs) •  Provide external marketplace knowledge of the latest category dynamics, trends and best practices •  Identify, prioritize and drive implementation of continuous improvement opportunities •  Utilize consistent methodologies to pursue deliverables that are aligned with strategic objec-tives and policies •  Attend work on a regular and predictable basis •  Complete assigned tasks in a safe manner and in a constant state of alertness •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE Bachelors Degree is required; an advanced degree is strongly preferred. 5-7 years of Category Management, Strategic Sourcing and Contract Negotiation experience with direct materials and services in the pharmaceutical industry. SAP/Purchasing system experience a plus. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satis-factorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to understand direct materials and services category market conditions, key suppliers within those markets, business pipeline and demand, and brand strategies •  Ability to measure and understand all aspects of supplier performance, category savings and areas for continuous improvement •  Understanding of the strategic sourcing process •  Proven results driving direct sourcing savings globally •  Experience negotiating complex contracts, including master service agreements and supply agreements •  Ability to translate strategic vision into tactical plans and manage the change required to ex-ecute plans •  Must possess the highest level of work ethics and integrity with the ability to maintain confi-dentiality of information. •  Possess strong organizational skills with the ability to take initiative to complete assignments and job responsibilities with minimal supervision •  Able to prioritize duties and contribute to multiple projects; including projects that are cross-functional and global •  The individual must be able to effectively interface with a variety of people and work well under stressful situations •  Must have excellent executive-level communication skills, including effective business writing and presentation skills •  Proficient in Microsoft Word, Excel and PowerPoint •  Must be able to learn tasks in Financial systems (e.g., SAP), Contract Management tools, and Spend Analytics tools with proper training and support •  Fluency in English (written and oral) required; fluency in Italian and/or French a plus  

Packaging Engineer
Wed, 22 May 2013 14:50:09 GMT

Packaging Engineer   JOB SUMMARY In this position, the Packaging Engineer will utilize their formulations and/or technical services background to support Global Supply Chain group with 3 rd Party Manufacturing.  Responsibilities  encompass technical knowledge in support of packaging operations, solid oral dose manufacturing, inhalable and injectable manufacturing, medical device and vitamins.  As a collaborative  partner, they will utilize their expertise in all aspects of product scale up, contract manufacturing, validation and technical support of 3 rd party manufacturing as well as internal support of solid oral dose facilities in North America.  Key contributor and practitioner in lean manufacturing projects across multiple sites and manage various transfer and scale-up projects throughout the global supply chain.     ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Manage scale up of new products, manufacturing feasibility batches, writing batch records and summarizing results for both 3 rd party and internal manufacturing. Provides technical leadership to the Global Supply Chain group for 3 rd party manufacturing companies. Apply specialty knowledge in the fields of medical devices, injectable, sterile and liquid filling processes to broad platform of products supported at 3 rd party manufacturing sites.  Determine appropriate use of packaging materials and processes to ensure acceptable product stability is obtained for all external packaging operations. Manage technical aspects of 3 rd party packaging sites.  Develop and execute studies for process, equipment, cleaning, facility, computer, and utility validation activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D) and products currently in commercial production to Aptalis, customer and Food and Drug Administration (FDA) requirements. Provide technical training and support to departments supported by the Technical Services/Validation departments (Third party GSC, Manufacturing, etc). Update, review, and approve Standard Operating Procedures (SOPs) and other official documents and determine if validation or re-validation is needed prior to approval of new or changed procedures.  Recommend new procedures or revisions were applicable. Participate in Factory Acceptance Testing (FAT) and/or due diligence testing and investigations. Collaborate with validation projects within the facility including execution of protocols and report writing. Technical expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, ovens, capsule fillers, packaging equipment and other pharmaceutical equipment. Ability to write basic computer/controller programs. Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3 rd party sites. Support engineering department with capital projects or trouble shooting of equipment and processes within the facility. Key contributor and practitioner of lean manufacturing programs within the facility Attends work on a regular and predictable basis. Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds all Company policies, including but not limited to, the Aptalis Code of Conduct and the Professional Conduct Policy and Prohibition Against Harassment Policy. Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. Supports the Aptalis vision and mission and exemplifies Aptalis values.         SUPERVISORY RESPONSIBILITY None.   EDUCATION AND/OR EXPERIENCE   B.S. in Packaging Engineering, Chemistry or other related technical field plus, 3-5 years of prior pharmaceutical experience preferred. Specific experience in the areas of packaging,  medical device, injectable/sterile processes as well liquids, cream and ointments is highly desired for this position. General knowledge of solid oral dose processing is a plus   QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Must have good working knowledge of the “Good Manufacturing Practices” Excellent interpersonal written and oral communication skills Proficient in Microsoft Office – Word and Excel Ability to coordinate, contribute to and work within a cross-functional teams. Ability to thrive in a dynamic and fast-paced environment. Able to prioritize duties and manage multiple projects from start to finish with minimal supervision. Ability to take initiative to complete assignments and job responsibilities with minimal supervision. Exceptional attention to detail and excellent organizational skills. Ability to accommodate up to 25-30% travel.   COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).   Aptalis Pharma is an Equal Opportunity Employer  

Associate Director, Quality
Wed, 22 May 2013 14:49:44 GMT

ASSOCIATE DIRECTOR, QUALITY   JOB SUMMARY: The essential job function is to assure Aptalis and its vendors comply with all FDA regulation and guidance documents. Provide direction, leadership and development to the Quality Assurance/Control and Operations staff. Develop, maintain and continuously improve the Quality System to assure conformance with all cGMP’s and regulatory requirements.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following. Other duties may be assigned. 1. Assure cGMP and regulatory compliance with all FDA and applicable external US regulatory requirements and guidance documents within Aptails and its vendors. 2. Direct and assure all Aptalis Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies. 3. Direct and manage all FDA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities. 4. Manage Aptalis’s audit program to include internal audits and vendor audits. 5. Manage and direct a vendor certification program. 6. Set and maintain appropriate policies and procedures to maintain regulatory compliance. 7. Coordinate customer and regulatory audits of Aptalis (Operations Group). 8. Develop quality systems for use at Aptalis to ensure production of quality product and all of its related activities (e.g. Engineering, QC). 9. Develop cGMP and other relevant Quality System training programs for Aptalis employees. 10. Approve all documentation used in relation to production of product and its related activities (validation, quality, control testing, engineering, etc.). 11. Lead and provide guidance to the compliance team. 12. Direct and manage the following specific activities: • Problem investigation systems (including “out of specifications”) • Annual product reviews • Customer complaints • Change control program • SOP, Batch Record System • Specifications • Provision of quality and production data for drug master files • Quality Manual preparation • Product release (intermediate and finished) • All regulatory documents and controls   13. Lead the personnel in accordance with Aptalis philosophies to include performance appraisals, training and development programs, team building, etc. 14. Identify resources required for effective and efficient operation of the department. 15. Recruit qualified and able personnel, as required, for the department. 16. Actively participate in the management of Aptalis and the development and implementation of policies. 17. Actively participate, with other managers, in the identification and resolution of problems related to Aptalis operation. 18. Communicate and provide leadership to staff to obtain good attitude, team effort, productivity, loyalty and quality improvements. Communicate concerns, needs and recommendations to management. 19. Provide and assist Regulatory with ANDA, NDA or IND applications as needed. 20. Follow other job-related instructions and perform other job-related tasks as requested.   GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy. Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: Produces value-added results through effective recruitment, delegation, performance management, training and development of employees in the following positions: Quality Assurance Manager and Quality Control Manager.   EDUCATION AND/OR EXPERIENCE: B.S./M.S. in Chemistry or other Physical Sciences fields with 5-15 years of industrial leadership experience, with minimum 10 years of Quality experience.   QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Interface with Manufacturing, R&D, Management personnel, customers, outside vendors, suppliers, consultants and government agencies. • Work with minimal supervision; review problems, issues or questions with supervisor. • Confidentiality of projects, test results, and both customer and Company information/data is a definite requirement. Thorough knowledge of: • cGMP, GLP and DEA regulations • NDA and ANDA requirements • Personal computers • Technical report writing along with good oral communication skills • Audit procedures   PHYSICAL REQUIREMENTS: 1. Physical Demands: The employee is required to: • Stand, walk, push, pull, twist, reach overhead, and bend to the floor; • Frequently moves items up to 50 pounds and occasionally required to move items or objects up to 100 pounds; • Occasionally required to climb ladders and/or steps to reach equipment. 2. Visual Ability: Visual accommodation necessary for reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details under microscope; must be able to distinguish color indicator changes in test solutions. 3. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes.   6. Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   The employee may be required to wear a respirator and must pass the required respirator evaluation test.   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position. While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Director, Pipeline Portfolio
Mon, 20 May 2013 16:32:08 GMT

JOB SUMMARY   Reporting to the VP, Global Licensing, the Director, Pipeline Portfolio will lead the commercial assessment of new product opportunities for the Aptalis Pharmaceutical Technologies (APT) development pipeline.  In addition, the Director, Pipeline Portfolio will coordinate the activities of the Product Concept Group (PCG), a multi-functional group charged with identifying, and evaluating new product opportunities   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned as needed. Develop systems and processes to manage the identification and evaluation of new product development opportunities; Coordinates the activities of the PCG ensuring that timelines and budgets are achieved; Act as the primary interface between the PCG and PT business function; Provide commercial assessment and insights on new product opportunities; Develop valuation models using internal and external data;  integrate the input of other PCG stakeholders and external experts in developing assessments of commercial viability for new product development opportunities; Identify commercial opportunities for innovative formulations or uses of already existing drugs; Generates ideas for new-product opportunities, and champions high value internal new product candidates for internally funded development; Responsible for preparing presentations of new product opportunities to Aptalis C-level management and to the Board, in order to secure internal funding for the development of these new opportunities; Other responsibilities as assigned.   EDUCATION BS/BA degree from a four-year accredited university or college, preferably in Business, Marketing, Economics, Finance or related field;  Science-related BS/BA with MBA highly preferred.  Other relevant advanced degrees (e.g., PhD) would be a plus. Minimum of ten (10) years of related experience in sales, business development and marketing, including new product assessment in a variety of therapeutic areas. Experience with drug delivery technologies, repurposing existing therapeutics, and products registered using 505(b)(2) pathway would be preferred.   EXPERIENCE AND QUALIFICATIONS    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Experience assessing opportunities to repurpose or re-formulate existing drugs (e.g., 505(b)(2) products); Experience contracting and collaborating with external vendors on commercial evaluations and studies; Experience in successful product launches; Experience conducting market research and developing commercial assessments of product opportunities.  Experience developing clinical and economic outcomes assessments. Particular experience identifying  key outcomes to patients and other stakeholders (including Health Technology Assessment bodies (HTAs) and payors); Ability, knowledge, skills and desire to interact with KOL’s, senior scientific and business function stakeholders within and outside of the company; Ability to lead and influence teams and work effectively in a collaborative environment; Displays thorough understanding of business environment sufficient to support key decisions, recommendations, planning, and execution; Demonstrates high level of proficiency in obtaining information, effectively allocating and applying resources in the best manner to meet company and project objectives; Ability to interface effectively with all levels of management and cross-functionally; Results-oriented with a willingness to take on responsibility and initiative; Excellent interpersonal written and oral communication skills; Attends work on a regular and predictable basis; Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds all Company policies, including but not limited to, the Aptalis Code of Conduct and the Professional Conduct Policy and Prohibition Against Harassment Policy; Works in a cooperative manner with managers, supervisors, coworkers, customers and the public; Supports the Aptalis vision and mission and exemplifies Aptalis values; Exceptional attention to detail and excellent organizational skills; Ability to accommodate up to 25% travel.

Temporary Process Engineer
Fri, 17 May 2013 13:35:21 GMT

Temporary Process Engineer Job Summary A process project engineer is responsible for supporting plant operations and capital projects, designing and installing control systems, as well as troubleshooting of process upsets and problems. They will also gather, design, configure, integrate and implement process control solutions for manufacturing including batch software, PLC, SCADA systems, and PC networking technology. Their goal is to develop and execute operational improvement projects within the product supply chain, maintain daily interaction with operating groups to drive improvement implementation, track ongoing success against completed tasks, actively lead teams, and provide individual contribution to problem solving efforts on selected projects to improve quality, reduce cost and improve processing cycle times. Aptalis is an Equal Opportunity Employer "EEO/M/F/DV". ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following. Other duties may be assgined. Develop and support process optimization efforts. Influence product formulation and optimize process parameters to best utilize facility equipment portfolio. Support start-up and scale-up activities. Build technical mastery and process understanding in self and others. Develop and execute equipment installation and operational qualifications. Programming and development of process control systems for manufacturing SCADA systems. Process and Project analysis, design & development System Engineering Technical information analysis Lead development of solutions and action plans to address transfer and start up issues. Ensure correct, up-to-date technical information is readily available and used by the operating teams. Assist in development of traning material. Support Production receipt of new Processes. GENERAL REQUIREMENTS: This position requires good attendance and a flexible work schedule since the position may require working on any of the three shifts, overtime, weekend hours, and possibly holidays.   All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY None.   EDUCATION AND/OR EXPERIENCE B.S. in Chemical, Mechanical or Industrial Engineering, or related field. Mechanical aptitude 5+ years of prior pharmaceutical or chemical experience preferred   QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Experience with Allen Bradley PLCs, Ci-Tech, Wonderware and IFix SCADA software packages. Must have good working knowledge of the “Good Manufacturing Practices” Familiar with word processing and spreadsheet programs (i.e. MS Word, MS Excel)   SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: Regular interaction with Manufacturing, Research and Development, Quality Assurance, Quality Control, Engineering, and management personnel will be expected.  Contact with customers, vendors, suppliers, consultants, and governmental agencies will be less frequent.   Assists in the execution of validation and qualification projects relating to equipment, systems, products, and processes whether they are new or legacy.   Maintaining confidentiality of projects, test results, and both customer and company information/data is a definite requirement.   PHYSICAL REQUIREMENTS Physical Demands:               The employee is required to: Stand, walk, push, pull, twist, reach overhead, and bend to the floor. Occasionally move items or equipment weighing up to 100 pounds. Occasionally required to climb ladders and/or steps to reach equipment. Visual Ability Requires reading blueprints, precision measuring devices, machine dials, gauges, and thermometers Must be able to observe fine details utilizing a microscope, when required. Hearing Ability Must be able to hear alarms, detect machine sounds, and malfunctioning equipment to identify and diagnose changes. Working Conditions The employee is subject to: High noise levels from operating machines. Breathing exposure to dust, mists, and fumes. Skin exposure to oils and chemicals.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personal protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed.   Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical. Aptalis complies with all applicable OSHA and EPA standards for environmental safety and employee health.   COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments)

Temporary Quality Control Analyst
Tue, 14 May 2013 15:45:57 GMT

TEMPORARY QUALITY CONTROL ANALYST This position is located in Vandalia, Ohio.   Aptalis is an Equal Opportunity Employer "EEO/M/F/DV".   BASIC FUNCTION: The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  •  Perform sampling of intermediate and finished products in accordance with cGMP guidelines. •  Perform physical and chemical testing of intermediate and finished products as described in the documented procedures •  Perform swabbing and analysis of clean equipment with moderate supervision. •  Maintain laboratory equipment and work areas in good working condition. •  Perform assigned calibrations for equipment in the laboratory. •  Recognize and report Out of Specification results, out of trend results and deviations to supervisor. •  Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures. •  Observes all safety procedures and regulations. •  Other job-related tasks as required •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: •  A Bachelor degree in Chemistry or related field. •  0 to 3 years experience in a Quality Control laboratory. •  High degree of oral and written communication skills. •  Experience with Microsoft Word, Excel and Access a plus. QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Interfaces with R&D personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, and Quality Assurance. •  Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. •  Confidentiality required due to access to written procedures regarding manufacturing and testing of products.  GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks.  Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for envi-ronmental safety and health. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Manager, Access & Reimbursement Services - Southeast
Fri, 10 May 2013 17:42:48 GMT

MANAGER, ACCESS & REIMBURSEMENT SERVICES (MARS) JOB SUMMARY The primary responsibility of the Manager, Access and Reimbursement Services is to achieve targeted payer access, optimal profitability, account development, and key product objectives for the full US corporate product portfolio.  This position will play a critical role in collaborating and organizing activities for a set of local market commercial teams to optimize its reimbursement environment in support of accomplishing key corporate goals. This position will cover FL, GA, AL, MS, LA, TN, KY, AR and will require approximately 50% travel.  This position should be located in Orlando, Atlanta, or near a major airport. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned.  Market  Access (Account Management) – 40%: •  Works closely with key decision makers and the processes that govern the reimbursement of Aptalis products at:      Regional payers (commercial, Medicare Part D and Medicaid);      Assigned state Medicaid FFS Programs and Exchanges;      Prioritized health systems (including integrated delivery systems, multispecialty group practices);      Other emerging customer segments (as identified by Managed Markets Leadership) •  Develops an annual payer/business Account Management plan with specific tactics for each assigned account across all prioritized Aptalis products. This includes SMART brand performance objectives and account face-to-face frequency objectives. •  Works closely with Manager, Payer Analytics to provide an annual forecast of projected sales and trends for each assigned account. •  Works closely with Medical Information and Medical Affairs to identify and address each assigned account’s evidence requirements for a positive clinical review of each Aptalis product. •  Actively works with assigned accounts to reduce prescribing barriers and patient OOP (Out of Pocket) burden to ensure appropriate access to and utilization of key products in targeted profitability ranges. •  Ensures continuous evaluation and prioritization of payer and institutional business to ensure optimal profitability. •  Interprets and integrates complex data to optimize key payer and institution opportunities across the assigned area. •  Keeps current on processes, filing requirements and timelines for new product market entries. Pull Through – 30%: •  Expectation of up to daily interaction with Managed Markets Corporate Accounts colleague(s) for bi-lateral information and best practices exchange relative to local market pull-through of prioritized corporate accounts. (Note: for those sub-national accounts under own management, a similar outreach effort will be required and will be overseen by the Director, Market Access). •  Assists the local commercial teams in driving sales, market share, thought leader development, and balancing of the profit equation. Will have aligned incentives based on  account and Sales geography overlay. •  Advises on optimal call plan targets (using Managed Markets decision support tools), tailored market access messaging and the use of approved patient support programs and tactics along with local Sales management to achieve sales objectives and gross to net objectives within Aptalis contracted accounts.  •  Interacts with Sales counterparts and acts as lead for all pull through efforts in assigned area including key state FFS & Managed Medicaid, commercial payer, and Medicare Part D initiatives. •  Interacts with Sales counterparts including a regular and active role at all meetings, regular field rides and ad hoc support of institutional formulary access initiatives. •  Actively engaged with Sales colleagues to identify prescribing barriers related to reimbursement in assigned area. •  Facilitates alignment with matrix (field and office) team members to ensure successful execution of product pull through plans •  Plays a key role in translating strategy into geographic region and payer segment specific goals, objectives, and plans and then successfully executing and achieving them. Reimbursement Services – 20%: •  Accountable for collaboratively developing and communicating commercial team’s local market reimbursement tactical plan for key products using available and PARC approved tools. •  In close collaboration with MM leadership and internal contracting/analytics team, Negotiates and implements high performance contracts that; achieve optimal patient OOP, support brand strategies and manage profitability margins. •  Works closely with internal contracting and analytics team members throughout the full contract life-cycle (including the pre-deal phase). •  Performs customer contract reviews at appropriate intervals to monitor progress. •  Develops a strong understanding and regularly communicates to local commercial team the Aptalis reimbursement value proposition as it relates to local managed market trends, benefit designs, health system consolidations and individual payers. Miscellaneous Duties – 10%: •  Expected to maintain a minimum of level 1 proficiency and regularly pursue ongoing improvement of the Managed Markets competencies specific to the MARS role. •  Provides key inputs into the monthly Managed Markets metrics reporting. •  Expected to meet all administrative expectations such as expense reporting, customer contact summaries, record keeping, business planning, calendar planning, etc. •  Work closely with all corporate team members and accomplish directed goals cross functionally •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY This job has no supervisory responsibility. EDUCATION AND/OR EXPERIENCE Requirements include the following: •  BS/BA degree from a four-year accredited university or college; MBA preferred; •  a minimum of five (5) years of demonstrated experience and proven success in biotech/ pharmaceutical industry; •  (For internal candidates) a minimum of two (2) years experience in institutional sales, sales management, reimbursement, contract strategy, managed care sales, marketing, Medicaid, VA/Military, or account management •  (For external candidates) a minimum of five (5) years experience in institutional sales, sales management, reimbursement, contract strategy, managed care sales, marketing, Medicaid, VA/Military, or account management QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Must possess thorough knowledge of US healthcare system (including federal, state and local programs) •  Excellent presentation skills and the ability to assimilate and analyze diverse data to develop tactical action steps to achieve sales results. •  Must possess strong leadership and selling skills to maximize performance results of the organization. •  Proficient in Microsoft Office, and strong understanding of pharmaceutical data sets and integration tools. •  Exceptional attention to detail and excellent organizational skills. •  Ability to identify the critical issues or opportunities using appropriate information and solve or elevate issues according to reach and severity •  Ability to prioritize responsibilities to meet regular and critical deadlines. •  Ability to contribute to and work within a cross-functional team. •  Excellent verbal and written communication and presentation skills. •  Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. •  Ability to thrive in a dynamic and fast-paced environment. •  Demonstrated ability to clearly and accurately interpret and follow procedures and policies. •  Ability to accommodate 50% travel.

Temporary, QC Analyst
Thu, 09 May 2013 15:01:39 GMT

    Temporary, QC Analyst JOB SUMMARY The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures.        ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Perform sampling of intermediate and finished products in accordance with cGMP guidelines. Perform physical and chemical testing of intermediate and finished products as described in the documented procedures Perform swabbing and analysis of clean equipment with moderate supervision. Maintain laboratory equipment and work areas in good working condition. Perform assigned calibrations for equipment in the laboratory. Recognize and report Out of Specification results, out of trend results and deviations to supervisor. Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures. Observes all safety procedures and regulations. Other job-related tasks as required Attends work on a regular and predictable basis. Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. Work effectively under production and sales deadlines.   SUPERVISORY RESPONSIBILITY None       EDUCATION AND/OR EXPERIENCE A Bachelor degree in Chemistry or related field 0 to 3 years experience in a Quality Control laboratory. High degree of oral and written communication skills. Experience with Microsoft Word, Excel and Access a plus     QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Interfaces with R&D personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, and Quality Assurance. Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. Confidentiality required due to access to written procedures regarding manufacturing and testing of products.    GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks.  Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   PHYSICAL REQUIREMENTS: Physical Demands: The employee is required to: stand, walk, push, pull, twist, reach overhead, and bend to the floor occasionally move items or equipment weighing up to 100 pounds occasionally required to climb ladders and/or steps to reach equipment Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.           Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. Manual Dexterity :       Must have steady hands and good physical coordination in order to handle delicate laboratory         instrumentation and equipment. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed.   Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health.     COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

QC Analyst (FTT)
Wed, 08 May 2013 20:19:04 GMT

                                                                          TEMPORARY QC ANALYST   JOB SUMMARY The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures.    ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.   Perform sampling of intermediate and finished products in accordance with cGMP guidelines. Perform physical and chemical testing of intermediate and finished products as described in the documented procedures Perform swabbing and analysis of clean equipment with moderate supervision. Maintain laboratory equipment and work areas in good working condition. Perform assigned calibrations for equipment in the laboratory. Recognize and report Out of Specification results, out of trend results and deviations to supervisor. Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures. Observes all safety procedures and regulations. Other job-related tasks as required Attends work on a regular and predictable basis. Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. Work effectively under production and sales deadlines.   SUPERVISORY RESPONSIBILITY None   EDUCATION AND/OR EXPERIENCE A Bachelor degree in Chemistry or related field 0 to 3 years experience in a Quality Control laboratory. High degree of oral and written communication skills. Experience with Microsoft Word, Excel and Access a plus   QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Interfaces with R&D personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, and Quality Assurance. Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. Confidentiality required due to access to written procedures regarding manufacturing and testing of products.    GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks.  Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   PHYSICAL REQUIREMENTS: Physical Demands: The employee is required to: stand, walk, push, pull, twist, reach overhead, and bend to the floor occasionally move items or equipment weighing up to 100 pounds occasionally required to climb ladders and/or steps to reach equipment Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.          Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. Manual Dexterity :       Must have steady hands and good physical coordination in order to handle delicate laboratory         instrumentation and equipment. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. Working Conditions:   The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed.   Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health.     COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary Manufacturing QA Specialist
Wed, 08 May 2013 20:00:16 GMT

TEMPORARY MANUFACTURING QA SPECIALIST This position is located in Vandalia, OH. JOB SUMMARY: The primary responsibility of this position is auditing and approving of Batch Production documentation (Batch Production Records, SOPs, logs etc.), and ensuring adherence to cGMP’s.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Audit and approve executed Batch Production Records. •  Review and approve Non-Conformance Investigations (Manufacturing, Calibration, SOP). •  Maintain and assure correctness of documentation. •  Interface with all departments within the company. •  Release Finished Product for shipment. •  Ensure facility adherence to cGMP’s and SOP’s. •  Maintain the confidentiality of pertinent information. •  Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management. •  Follow other job-related instructions and perform other tasks as required.   GENERAL REQUIREMENTS: •  This position requires a forty hour work week.  •  Position may require working overtime and weekend hours, as necessary. •  All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: None.   EDUCATION AND/OR EXPERIENCE: •  Bachelor’s Degree preferred, with 0-2 years of Quality experience. •  Knowledge in cGMP’s as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment. •  Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation system is highly preferred.   QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satis-factorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Accuracy and neatness of compiling documents are required. •  Good oral and written communication skills. •  Audits and approves Batch Production documentation •  Interfaces with all internal departments within the company •  Receives supervision as necessary •  Confidentiality of pertinent information is required   PHYSICAL REQUIREMENTS: •  The employee must be able to stand, walk, push, twist, reach overhead, and bend to the floor. •  The employee must have visual sharpness for reading written instructions and computer screen.   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Scientist, Analytical
Tue, 07 May 2013 20:03:28 GMT

ANALYTICAL SCIENTIST   JOB SUMMARY : The essential job function is to oversee development and validation of analytical methods for raw materials, work-in-process, and finished products.  Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”. ESSENTIAL DUTIES AND RESPONSIBILITIES : The essential job function is to oversee development and validation of analytical methods for raw materials, work-in-process, and finished products.  MAJOR RESPONSIBILITIES : •  Develop and validate analytical methods, utilizing appropriate instrumentation (e.g. HPLC, dissolution, GC). •  Collect and compile necessary literature to support the development process; utilizing all necessary information available from publications such as USP, NF, BP, JEP, Florey, etc. •  Record all work and data in the approved laboratory notebooks. •  Comply with all regulations as specified by OSHA, EPA, FDA, etc., and as defined in Corporate Hygiene plan. •  Prepare and/or revise technical reports and other documents. •  Ensure all necessary equipment, supplies and reagents are ordered in advance of need. •  Assist in transferring analytical procedures to Quality Control. •  Train other analytical chemists and technicians. •  Stay abreast of government regulations and assure that other chemists are trained and informed on all aspects of regulations. •  Maintain laboratory equipment and perform analytical troubleshooting and minor repairs on lab equipment. •  Follow and perform other job-related duties as requested. GENERAL REQUIREMENTS : The position requires good attendance, a standard eight-hour day, and five-day work week.  The employee must be fluent in written and spoken English.  Position may require working overtime and weekends. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITY : None. EDUCATION AND/OR EXPERIENCE : •  MS in Analytical Chemistry or equivalent degree in physical sciences with a minimum of 5 years or PhD with minimum of two years of relevant laboratory experience, BS with a minimum of 8 years.  QUALIFICATIONS :  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  In-depth knowledge of Pharmaceutical operations, including lab procedures and equipment, instrumentation, safety procedures, and laboratory practices; mathematical analysis and statistical computations; government regulations.  •  Working knowledge of personal computers and legible handwriting. •  Interface with internal and external customers and vendors. •  Ability to work independently. PHYSICAL REQUIREMENTS : 1. The employee is required to:     •  Stand, walk, push, twist, reach overhead, and bend to the floor.     •  Frequently move items up to 50 pounds and occasionally required to move items or objects up to 100 pounds.     •  Occasionally required to climb ladders and/or steps to reach equipment. 2. Visual Ability: Visual accommodation necessary for reading precision measuring equipment, machine dials, gauges, and thermometers; must be able to observe fine details under microscope; must be able to distinguish color indicator changes in test solution. 3. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. 6. Working Conditions: The employee is subject to:     •  High noise levels from operating machinery     •  Skin exposure to oils, vapors, and a variety of chemicals.  (Required to wear gloves when working with hazardous materials.)     •  Breathing exposure to dust, mists, and fumes The employee may be required to wear a respirator and must pass the required respirator evaluation test. COMPANY POSITION STATEMENT : This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments ).

Analyst, Financial Planning & Analysis
Tue, 07 May 2013 18:39:26 GMT

Analyst, Financial Planning & Analysis   JOB SUMMARY Responsible for the cost accounting system maintenance and analysis related. Also responsible for supporting department managers in the decision making related to the financial aspects of the Manufacturing and Quality department. Participates in the development of the annual planning and contributes to upholding the financial health .   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned.   Participates in calculating the cost of product for the PT business segment at item creation, in the budget process and for business development purposes. Participates in the preparation of indicators that allow performance measurement of the operations. Follows-up on relevant performance indicators and pre-identified targets. Collaborates with department managers during the preparation of the strategic plan. Actively participates in the preparation of the annual plan (budget), in the preparation of appropriate cost drivers, and in the budgetary control.  Carries out the monthly analysis of the budget variances. Participates in the preparation of the quarterly and revised annual forecasts (LBE). Develops and prepares relevant management reports in order to meet the needs of the Manufacturing and Quality department managers. Prepares various communications presented to department’s managers. Works with the Manufacturing and Quality department managers in order to identify improvement opportunities related to the financial management of their projects. Stays up-to-date on the best practices in order to best advise the clients. Develops and maintains relationships within the financial services and with other departments in order to ensure optimal exchange of information. Supports the financial services with different demands of analysis related to the Manufacturing and Quality department.   Other   Attends work on a regular and predictable basis. Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. Works effectively under deadlines.     SUPERVISORY RESPONSIBILITIES None     EDUCATION AND/OR EXPERIENCE College degree in accounting or the equivalent together with a minimum of five (5) years of relevant experience that includes experience in a manufacturing company as cost accountant. Holder of a relevant professional title: CPA . Experience in a pharmaceutical company is an asset.     QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   Cost accounting knowledge and experience. Abilities in communication and interpersonal relations with internal clients and external partners / stakeholders. Ability in advising managers and influencing the decisions within his department. Abilities in project management. Quality in planning and work organization. Respect of confidentiality in all aspects of work. Capacity for synthesizing and analyzing. Ability to work under pressure. Good knowledge of operation of an accounting program (AX and/or SAP is an asset). Good knowledge of operation of Cognos TM1. Good knowledge of generally accepted accounting principles. Quality of judgement and evaluation of situations. Business sense. Ability to adapt in a fast-changing environment. Proficiency in Microsoft Office suite. Excellent oral and written skills both in English, Italian is an asset.     COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary Warehouse Operator
Tue, 07 May 2013 14:26:58 GMT

TEMPORARY WAREHOUSE OPERATOR       This position is located in Vandalia, Ohio.   Aptalis an Equal Opportunity Employer “EEO/M/F/DV”.   JOB SUMMARY : The essential job function is to provide proper warehouse management assistance in handling materials, work in-process, finished products and other miscellaneous items. ESSENTIAL DUTIES AND RESPONSIBILITIES : The primary duties and responsibilities of this position include the following.  Other duties may be assigned. • Prepares finished product for shipment to customer to include pulling and matching outgoing orders, inspecting and labeling finished drums, recording seal numbers, and preparing shipping documents. • Receive raw materials to include unloading drums, categorizing and verifying materials, inspecting, following hazardous materials procedures, and entering receipts into AX. • Completes appropriate paperwork for QC to release and transport raw materials in warehouse. • Takes inventory of raw materials and finished products as requested. Maintains inventory of shipping materials and supplies. • Responsible for sampling and labeling of raw materials being received and as requested. • Operates lift truck to move, convey, or hoist shipments from shipping/receiving platform to storage or work area. Responsible for maintenance of lift truck. • Prepares, handles and labels various hazardous and non-hazardous waste materials for disposal. • Maintains proper warehouse orderliness, cleanliness and safety. • Receives packages from small freight carriers (UPS, Federal Express, etc.).  Inspects receipts and delivers items to proper individuals.  Packages and ships item for UPS, Federal Express, etc. • Follows other job-related instructions and performs other job related tasks as assigned. • Attends work on a regular and predictable basis. • Completes assigned tasks in a safe manner and in a constant state of alertness. • Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. • Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. • Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY : None EDUCATION AND/OR EXPERIENCE : • High school diploma or equivalency. • 3-5 years material handling experience. GENERAL REQUIREMENTS :  All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. PHYSICAL REQUIREMENTS : 1. Physical Demands: The employee is required to: • drive vehicles, including but not limited to trucks under 26,000  GVW • stand, walk, push, pull, twist, reach overhead, and bend to the floor • exerts 10-20 pounds of force frequently, and/or • exerts up to 100 pounds of force daily, • moderate amounts of hammering when making and opening crates and boxes, • occasionally uses ladders to climb into trucks for loading and unloading; also climbs stairs, • temperature varies with outside weather conditions as incumbent is exposed to cold and heat when loading and unloading truck. • able to lift up to 80 pounds. 2. Visual Ability: Visual accommodation necessary for reading lists, documents, and driving vehicles. 3. License Required: Valid Driver’s License 4. Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. 5. Working Conditions: The employee is subject to: • high noise levels from operating machines • breathing exposure to dust, mists, and  fumes • skin exposure to oils and chemicals Employee whose vocation requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personal protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA and EPA standards for environmental, safety and health. QUALIFICATIONS :  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED : • Interfaces with R&D personnel and Quality Control • Receives daily supervision with supervisor making daily check on performance. COMPANY POSITION STATEMENT : This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator 1
Tue, 07 May 2013 14:26:30 GMT

  TEMPORARY BATCH OPERATOR   This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).    

Temporary Batch Operator 1
Tue, 07 May 2013 14:25:46 GMT

TEMPORARY BATCH OPERATOR     This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator 1
Tue, 07 May 2013 14:25:29 GMT

TEMPORARY BATCH OPERATOR   This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator 1
Tue, 07 May 2013 14:23:54 GMT

TEMPORARY BATCH OPERATOR This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator 1
Tue, 07 May 2013 14:22:18 GMT

  TEMPORARY BATCH OPERATOR   This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator 1
Tue, 07 May 2013 14:21:33 GMT

TEMPORARY BATCH OPERATOR     This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary Batch Operator 1
Tue, 07 May 2013 14:21:11 GMT

TEMPORARY BATCH OPERATOR   This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary, QC Analyst
Tue, 07 May 2013 14:19:36 GMT

TEMPORARY QUALITY CONTROL ANALYST   This position is located in Vandalia, Ohio.     Aptalis is an Equal Opportunity Employer "EEO/M/F/DV".   BASIC FUNCTION: The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  •  Perform sampling of intermediate and finished products in accordance with cGMP guidelines. •  Perform physical and chemical testing of intermediate and finished products as described in the documented procedures •  Perform swabbing and analysis of clean equipment with moderate supervision. •  Maintain laboratory equipment and work areas in good working condition. •  Perform assigned calibrations for equipment in the laboratory. •  Recognize and report Out of Specification results, out of trend results and deviations to supervisor. •  Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures. •  Observes all safety procedures and regulations. •  Other job-related tasks as required •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: •  A Bachelor degree in Chemistry or related field. •  0 to 3 years experience in a Quality Control laboratory. •  High degree of oral and written communication skills. •  Experience with Microsoft Word, Excel and Access a plus. QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Interfaces with R&D personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, and Quality Assurance. •  Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. •  Confidentiality required due to access to written procedures regarding manufacturing and testing of products.  GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks.  Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for envi-ronmental safety and health. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary QC Analyst
Tue, 07 May 2013 14:19:04 GMT

TEMPORARY QUALITY CONTROL ANALYST   This position is located in Vandalia, Ohio.   Aptalis is an Equal Opportunity Employer "EEO/M/F/DV".   BASIC FUNCTION: The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  •  Perform sampling of intermediate and finished products in accordance with cGMP guidelines. •  Perform physical and chemical testing of intermediate and finished products as described in the documented procedures •  Perform swabbing and analysis of clean equipment with moderate supervision. •  Maintain laboratory equipment and work areas in good working condition. •  Perform assigned calibrations for equipment in the laboratory. •  Recognize and report Out of Specification results, out of trend results and deviations to supervisor. •  Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures. •  Observes all safety procedures and regulations. •  Other job-related tasks as required •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: •  A Bachelor degree in Chemistry or related field. •  0 to 3 years experience in a Quality Control laboratory. •  High degree of oral and written communication skills. •  Experience with Microsoft Word, Excel and Access a plus. QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Interfaces with R&D personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, and Quality Assurance. •  Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. •  Confidentiality required due to access to written procedures regarding manufacturing and testing of products.  GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks.  Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for envi-ronmental safety and health. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary, Raw Materials Specialist
Tue, 07 May 2013 14:18:19 GMT

Temporary, Raw Material Specialist   JOB SUMMARY The essential job function is to perform physical and chemical testing of raw materials in accordance with written procedures and compendia guidelines. Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Perform sampling of raw materials in accordance with cGMP guidelines. Perform physical and chemical testing of raw materials as described in the documented procedures. Assist in compiling samples for send out testing. Maintain laboratory equipment and work areas in good working condition. Perform assigned calibrations for equipment in the laboratory. Recognize and report Out of Specification results, out of trend results and deviations to supervisor. Revise Raw Material documentation as needed (i.e. certificates of analysis, test methods, specification sheets. Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures. Observes all safety procedures and regulations. Other job-related tasks as required.   GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks. Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy. Failure to abide by these requirements may result in the employee’s immediate termination.   PHYSICAL REQUIREMENTS: Physical Demands: The employee is required to: stand, walk, push, pull, twist, reach overhead, and bend to the floor occasionally move items or equipment weighing up to 100 pounds occasionally required to climb ladders and/or steps to reach equipment. Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes . Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health.   SUPERVISORY RESPONSIBILITY None.   EDUCATION AND/OR EXPERIENCE: A Bachelor degree in Chemistry or related field. 0 to 3 years experience in a Quality Control or Raw Material laboratory   QUALIFICATIONS   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Interfaces with R&D personnel, Manufacturing, Quality Control Microbiology, Supply Chain, Quality Control and Quality Assurance. Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. Confidentiality required due to access to written procedures regarding manufacturing and testing of products. High degree of oral and written communication skills. Experience with Microsoft Word, Excel and Access a plus.   COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary, Raw Materials Specialist
Tue, 07 May 2013 14:17:41 GMT

Temporary, Raw Material Specialist   JOB SUMMARY The essential job function is to perform physical and chemical testing of raw materials in accordance with written procedures and compendia guidelines. Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Perform sampling of raw materials in accordance with cGMP guidelines. Perform physical and chemical testing of raw materials as described in the documented procedures. Assist in compiling samples for send out testing. Maintain laboratory equipment and work areas in good working condition. Perform assigned calibrations for equipment in the laboratory. Recognize and report Out of Specification results, out of trend results and deviations to supervisor. Revise Raw Material documentation as needed (i.e. certificates of analysis, test methods, specification sheets. Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures. Observes all safety procedures and regulations. Other job-related tasks as required.   GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks. Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy. Failure to abide by these requirements may result in the employee’s immediate termination.   PHYSICAL REQUIREMENTS: Physical Demands: The employee is required to: stand, walk, push, pull, twist, reach overhead, and bend to the floor occasionally move items or equipment weighing up to 100 pounds occasionally required to climb ladders and/or steps to reach equipment. Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes . Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health.   SUPERVISORY RESPONSIBILITY None.   EDUCATION AND/OR EXPERIENCE: A Bachelor degree in Chemistry or related field. 0 to 3 years experience in a Quality Control or Raw Material laboratory   QUALIFICATIONS   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Interfaces with R&D personnel, Manufacturing, Quality Control Microbiology, Supply Chain, Quality Control and Quality Assurance. Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. Confidentiality required due to access to written procedures regarding manufacturing and testing of products. High degree of oral and written communication skills. Experience with Microsoft Word, Excel and Access a plus.   COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary, Raw Materials Specialist
Tue, 07 May 2013 14:16:58 GMT

Temporary, Raw Material Specialist   JOB SUMMARY The essential job function is to perform physical and chemical testing of raw materials in accordance with written procedures and compendia guidelines. Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Perform sampling of raw materials in accordance with cGMP guidelines. Perform physical and chemical testing of raw materials as described in the documented procedures. Assist in compiling samples for send out testing. Maintain laboratory equipment and work areas in good working condition. Perform assigned calibrations for equipment in the laboratory. Recognize and report Out of Specification results, out of trend results and deviations to supervisor. Revise Raw Material documentation as needed (i.e. certificates of analysis, test methods, specification sheets. Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures. Observes all safety procedures and regulations. Other job-related tasks as required.   GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks. Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy. Failure to abide by these requirements may result in the employee’s immediate termination.   PHYSICAL REQUIREMENTS: Physical Demands: The employee is required to: stand, walk, push, pull, twist, reach overhead, and bend to the floor occasionally move items or equipment weighing up to 100 pounds occasionally required to climb ladders and/or steps to reach equipment. Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes . Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment. Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health.   SUPERVISORY RESPONSIBILITY None.   EDUCATION AND/OR EXPERIENCE: A Bachelor degree in Chemistry or related field. 0 to 3 years experience in a Quality Control or Raw Material laboratory   QUALIFICATIONS   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Interfaces with R&D personnel, Manufacturing, Quality Control Microbiology, Supply Chain, Quality Control and Quality Assurance. Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. Confidentiality required due to access to written procedures regarding manufacturing and testing of products. High degree of oral and written communication skills. Experience with Microsoft Word, Excel and Access a plus.   COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary, QA Specialist
Tue, 07 May 2013 14:15:42 GMT

Temporary QA Auditor   JOB SUMMARY The primary responsibility of this position is the auditing and approving of quality analytical documentation (test sheet, analytical notebooks, SOPs, logs etc.), and ensuring adherence to cGMP’s .   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Audit and approve executed commercial analytical testing records. Review and approve Out of Specification (OOS) Investigations and results. Review and approve Non-Conformance Investigations (Raw Material, QC, SOP). Maintain and assure correctness of quality documentation. Interface with all departments within the company. Release Finished Product for shipment. Ensure facility adherence to cGMP’s and SOP’s. Maintain the confidentiality of pertinent information. Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management. Follow other job-related instructions and perform other tasks as required.   GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. This position requires a forty hour work week.  Position may require working overtime and weekend hours, as necessary.   SUPERVISORY RESPONSIBILITY None.   EDUCATION AND/OR EXPERIENCE Bachelor’s Degree in a Physical/Life Science field preferred, with 0-2 years of Quality experience.   QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Knowledge in cGMP’s as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment. Understanding and/or working experience of laboratory processes and equipment. Accuracy and neatness of compiling documents are required. Good oral and written communication skills.   PHYSICAL REQUIREMENTS: The employee must be able to stand, walk, push, twist, reach overhead, and bend to the floor. The employee must have visual sharpness for reading written instructions and computer screen.   SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: Audit quality analytical documentation Interfaces with all internal departments within the company Receives supervision as necessary Confidentiality of pertinent information is required     COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Manager, Manufacturing
Mon, 06 May 2013 15:05:04 GMT

MANUFACTURING MANAGER   JOB SUMMARY : The basic job function is to manage and coordinate the functions of manufacturing department and related activities.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES : The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Manage the activities of the Manufacturing department to ensure timely, cost effective and efficient production of products for Aptalis. •  Ensure compliance of the Manufacturing department with all relevant Aptalis and FDA/cGMP regulations, guidelines and policies. •  Ensure compliance of the Manufacturing department with all relevant Aptalis, federal safety and environmental regulations, guidelines and policies. •  Ensure compliance of the Manufacturing department with all relevant Aptalis and DEA guidelines, with reference to production and handling of controlled and scheduled products. •  Develop improvement plans for the Manufacturing department within all relevant guidelines. •  Manage Manufacturing personnel in accordance with Aptalis philosophies to include performance appraisals, training and development programs, goals and objects, and budgetary conformance. •  Identify resources required for effective and efficient operations. •  Recruit qualified and able personnel, as required, for the department. •  Actively participate in the management of Aptalis and the development and implementation of policies. •  Actively participate, with other managers, in the identification and resolution of problems related to Aptalis operations. •  Communicate and provide leadership to staff to obtain good attitude, team effort, productivity, loyalty and quality improvements.  Communicate concerns, needs and recommendations to management. •  Train and develop the supervisors and team leaders of the department to provide a succession plan for the department. •  Follow other job-related instructions and perform other job-related tasks as requested.   GENERAL REQUIREMENTS : All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. EDUCATION AND/OR EXPERIENCE : •  B.S. in Chemical Engineering or Scientific related degree.  Candidate should possess high leadership skills that are conducive to stimulating a high productivity level as well as creating a highly effective culture. •  7 or more years experience in manufacturing operations, preferably in the pharmaceutical industry. •  High degree of oral and written communication skills   QUALIFICATIONS :  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Requires knowledge and/or management of all current Good Manufacturing Practices, as well as, experience within operations such as technical services, laboratories, plant engineering and maintenance, materials and logistics and/or other related operational departments.   SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED : •  Interfaces with R&D personnel, Manufacturing, Engineering, Logistics, Quality Control,  Quality Assurance, outside vendors, tour groups, and customers. •  Incumbent exhibits high degree of independence, receiving minimal supervision. •  Confidentiality required due to access to blueprints and written procedures regarding manufacturing of products.  Also deals with confidential salary data. •  High degree of communication required to interface with other employees, customers and suppliers.   PHYSICAL REQUIREMENTS : 1. Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2. Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6. Working Conditions:    The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed.   Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis America, Inc. complies with all applicable OSHA, and EPA, standards for environmental safety and health.   COMPANY POSITION STATEMENT : This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Manager, Market Analysis - Pharmaceutical Technologies
Thu, 25 Apr 2013 15:42:58 GMT

MANAGER, MARKET ANALYSIS - PHARMACEUTICAL TECHNOLOGIES JOB SUMMARY The Manager, Market Analysis, will support Global Sales and Licensing activities for all Pharmaceutical Technologies. He/she will contribute to growing revenues of the PT business by providing evaluations of products, markets, customers, competitors. In addition he/she will provide analysis of the PT business by using sales trends, time to close (for contracts), and other parameters to benchmark and evaluate the PT business performance.   This position will also support the out-licensing activities by identifying out-licensing opportunities and providing valuation for this potential business; The position will assist with negotiations to amend existing agreements and bring new opportunities to contract.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following. Other duties may be assigned. Specific duties of the position include: •  Supports the achievement of overall PT objectives, strategies and tactics for growth of Aptalis’ business. •  Assists with negotiations of product license  and sales agreements. •  Keeps abreast of competitor activities and provides reports. •  Leads analysis and interpretation of sales data from external (IMS) data and internal sources. •  Provides financial and market analysis of existing portfolio products and for new licensing opportunities. •  The Manager, Market Analyst will develop scenarios based on financial and market analysis, and provide recommendations to increase revenues and profitability of existing portfolio and assess of new licensing opportunities. •  The incumbent will monitor revenues and deal flows by measuring the different stages of the ongoing licensing activities in order to provide a forecast of expected licensing deals and associated revenues and timing. •  Prepare Pharmaceutical Technologies long term financial projections based on expected deals and on existing portfolio. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies including the Professional Conduct Policy and Prohibition against Harassment Policy and the Business Ethics and Conduct Code. •  Works in a cooperative manner with manager, supervisors, coworkers, customers and the public. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE BS/BA (economics or business) degree from a four year accredited university or college required; MBA preferred Minimum of three years of pharmaceutical industry experience in similar positions. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   •  Ability to carry out valuations of products, markets, companies, etc using various methods including ratios, DCF etc. •  Good knowledge of financial principles (NPV, Risk, Return, Cost of Capital, etc.) •  Ability to assess short- and long-term market potential •  In depth knowledge of global pharmaceutical markets (with a focus on US, Europe, Japan) •  Good understanding of commercial operations, research and development and regulatory processes. •  The individual must be able to effectively interface with a variety of people and work well under stressful situations •  Strong business and financial acumen. •  Excellent analytical skills •  Proficient in Microsoft Word, Excel (including use of macros) and PowerPoint •  Fluency in English (written and oral) required; knowledge of Italian a plus

QA, Systems Coordinator
Thu, 25 Apr 2013 15:41:17 GMT

Systems Coordinator JOB SUMMARY : The primary responsibility of this position is to assist the QA systems group in maintaining all Quality Systems (CAPA, Non-Conformance, Trending, Customer Complaint, System/Process Change Control, etc.), and ensuring adherence to cGMP’s.       Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.       ESSENTIAL DUTIES AND RESPONSIBILITIES : The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Assist in Maintaining Quality Systems including: CAPA, Non-Conformance, Trending, Customer Complaints, Change Management, etc. •  Assists in Annual Product Review writing, routing, and filing. •  Assists with gathering information for customer requests. •  Assist with Customer/Regulatory audits as necessary. •  Gather data and generate quality systems report in Excel, Word, and PowerPoint. •  Maintain the confidentiality of pertinent information. •  Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management. •  Follow other job-related instructions and perform other tasks as required.     GENERAL REQUIREMENTS : All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.     SUPERVISORY RESPONSIBILITY : None.     EDUCATION AND/OR EXPERIENCE : •  Associates Degree preferred, with 0-2 years of Quality and/or Regulatory Compliance experience. •  Knowledge in cGMP’s as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment. •  Understanding of Quality Systems pertaining to a bulk pharmaceutical and solid oral dosage manufacturing environment is preferred.     QUALIFICATIONS :  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Accuracy and neatness of compiling documents are required. •  Good oral and written communication skills. •  Advanced in Excel, Word, Access, and PowerPoint. •  Ability to trend and track metrics as well as perform statistical analysis on the data.     SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED : •  Moderate degree of communication required to interface with personnel from all departments, and outside customers. •  Must exhibit a high degree of independence, receiving minimal supervision. •  Confidentiality required due to access to written procedures and batch records.     PHYSICAL REQUIREMENTS : The employee is required to: •  Stand, walk, push, pull, twist, reach overhead, and bend to the floor. 1. Visual Requirements: •  The employee must have visual sharpness for reading written instructions and computer screen.     COMPANY POSITION STATEMENT : This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Contracts Paralegal
Wed, 24 Apr 2013 20:00:07 GMT

CONTRACTS PARALEGAL JOB SUMMARY The Contracts Paralegal will be a member of the Global Legal team and will provide support to the Global Pharmaceutical Development and Global Clinical & Regulatory Affairs business groups. Responsibilities include working with client groups to prepare template agreements for research and development activities in support of the clinical, regulatory, clinical quality assurance, pipeline strategies, medical affairs, pharmacovigilance and pharmaceutical development client groups; and assisting with the contract management process from draft through execution.    ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following; provided, however, other duties may be assigned. •  Assists with the preparation, review, edit and negotiation of legal contracts, including confidentiality disclosure agreements, master service agreements, consulting agreements, clinical trial agreements, development agreements and other research and development related agreements. •  Acts as first point of contact for the Pharmaceutical Development and Global Clinical & Regulatory Affairs client groups for all contract requests. •  Coordinates with outside counsel on legal issues. •  Manages changes in contract scope, change orders, and amendments to ensure accurate and timely revisions to terms and/or services. •  Assists Legal Team in identifying areas for improvement in template contracts. •  Reviews changes to standard contract templates and ensures compliance with relevant internal policies (e.g., Authorization Policy). •  Researches and evaluates potential liability exposure in areas of research and development contracts, on an as needed basis. •  Assists with computerized system for organizing, maintaining, administering and tracking existing written contracts. •  Performs other duties and projects as needed. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE 6+ years of contract paralegal experience or related experience in a law firm (working on pharmaceutical contracts) or in the pharmaceutical industry is required. BS/BA degree from a four-year accredited university or college preferred. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to manage a high volume of contract requests. •  Ability to effectively and positively work with senior-level internal personnel and outside counsel. •  Ability to foster teamwork, demonstrate political savvy and composure, and manifest trust. •  Ability to maintain the highest degree of confidentiality and integrity. •  Able to prioritize duties and manage multiple matters from start to finish with minimal supervision. •  Exceptional attention to detail and excellent organizational skills. •  Strong interpersonal, written and oral communication skills •  Proficient in Microsoft Office. •  Ability to thrive in a dynamic and fast-paced global environment. •  Demonstrates sound judgment, decision making and discretion •  Ability to coordinate, contribute to and work within a cross-functional team. •  Ability to work some overtime hours, if requested.

Regional Sales Manager
Tue, 23 Apr 2013 21:10:34 GMT

REGIONAL SALES MANAGER  JOB SUMMARY The primary responsibility of the Regional Business Unit Manager (RSM) is to successfully implement sales and marketing plans, achieve or exceed sales goals for volume and profitability, and manage field sales representatives and expenses in an assigned region. *This position can be located in Houston, Dallas/Ft. Worth, San Antonio or Austin. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Leading the regional sales effort to achieve or exceed sales goals. •  Recommending sales department appointments, promotions, etc. for the assigned region. •  Monitoring and controlling regional sales departmental budgets. •  Implementing the training and development of field sales personnel. •  Participating in meetings to contribute to overall Company operations, field sales salary review process and the development of marketing plans. •  Conducting semi-annual business reviews with sales representatives. •  Interacting with office staff on behalf of field sales personnel to ensure proper communications and appropriate cooperation. •  Be knowledgeable of competitive products, techniques, and activities. •  Maintain a neat and professional appearance at all business functions. •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY Supervises field sales representatives as assigned. EDUCATION AND/OR EXPERIENCE Bachelor’s degree from four-year accredited college or university, Master’s degree preferred. A minimum of four years pharmaceutical sales experience required, management experience preferred. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  The ability to attract, hire and retain top performers. •  Proven ability and willingness to lead and work effectively with others in order to achieve organizational goals •  Ability to remain focused on priorities, goals, and objectives •  Proven ability to influence others and maintain the image and behavior of a leader •  Ability to accommodate extensive travel. •  Possess a valid driver’s license in the state of residence.  Also, must possess and maintain a driving record that is acceptable to the Company. •  Proficient in Microsoft Word, Excel and PowerPoint. PHYSICIAL DEMANDS •  While performing the duties of this job, the employee is required to travel by air and automobile. •  The employee must occasionally lift and/or move up to 60 pounds.

Regional Sales Manager
Tue, 23 Apr 2013 19:55:24 GMT

REGIONAL SALES MANAGER  JOB SUMMARY The primary responsibility of the Regional Business Unit Manager (RSM) is to successfully implement sales and marketing plans, achieve or exceed sales goals for volume and profitability, and manage field sales representatives and expenses in an assigned region. *This position can be located in Houston, Dallas/Ft. Worth, San Antonio or Austin. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Leading the regional sales effort to achieve or exceed sales goals. •  Recommending sales department appointments, promotions, etc. for the assigned region. •  Monitoring and controlling regional sales departmental budgets. •  Implementing the training and development of field sales personnel. •  Participating in meetings to contribute to overall Company operations, field sales salary review process and the development of marketing plans. •  Conducting semi-annual business reviews with sales representatives. •  Interacting with office staff on behalf of field sales personnel to ensure proper communications and appropriate cooperation. •  Be knowledgeable of competitive products, techniques, and activities. •  Maintain a neat and professional appearance at all business functions. •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY Supervises field sales representatives as assigned. EDUCATION AND/OR EXPERIENCE Bachelor’s degree from four-year accredited college or university, Master’s degree preferred. A minimum of four years pharmaceutical sales experience required, management experience preferred. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  The ability to attract, hire and retain top performers. •  Proven ability and willingness to lead and work effectively with others in order to achieve organizational goals •  Ability to remain focused on priorities, goals, and objectives •  Proven ability to influence others and maintain the image and behavior of a leader •  Ability to accommodate extensive travel. •  Possess a valid driver’s license in the state of residence.  Also, must possess and maintain a driving record that is acceptable to the Company. •  Proficient in Microsoft Word, Excel and PowerPoint. PHYSICIAL DEMANDS •  While performing the duties of this job, the employee is required to travel by air and automobile. •  The employee must occasionally lift and/or move up to 60 pounds.

Temporary Batch Operator 1 (FTT)
Fri, 19 Apr 2013 13:52:08 GMT

TEMPORARY BATCH OPERATOR   This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Operator (FTT)
Fri, 19 Apr 2013 13:51:00 GMT

OPERATOR I (Full-Time Temporary) This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Manager, Formulations
Wed, 17 Apr 2013 20:17:15 GMT

FORMULATIONS MANAGER   JOB SUMMARY The position is responsible for proposing, screening, evaluating and implementing product and technology development projects.   It is also the responsibility of this position to lead, direct, and prioritize projects assigned to this position and associated Formulation staff. Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Lead in the development of new drug delivery technologies and products. Keep current with regulations and technical knowledge.  Secure and provide adequate scientific formulation support to all assigned projects. Interface with internal and external clients in project meetings. Assist Business Development in preparation of R&D project proposals.  Provide input on the technical feasibility and resources required of the project. Provide cost and man-hour estimates associated with R&D project proposals. Direct priorities for within the position. Provide input on project planning. Ensure all activities comply with OSHA, EPA, DEA and cGMP's regulations. Maintain detailed records of all work to ensure compliance of all product submissions to the requirements by government agencies. Prepare and review CMC text for NDA/ANDA/DMF and other regulatory filings. Prepare and review master batch records, development pharmaceutics reports and other formulation documents. Provide necessary training and mentoring to junior Formulation staff. Participate in the interview and hiring of quality individuals to fill needed roles. Perform other tasks as requested by the Senior Director of Research and Development   GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY Produces value-added results through effective recruitment, delegation, performance management, training and development of employees in the following positions:   EDUCATION AND/OR EXPERIENCE Minimum of a PhD Degree in Pharmaceutical Sciences or a related field with 6-10 years experience in the pharmaceutical industry.    Solid background in pharmaceutics, biopharmaceutics or processing technologies in order to be able to invent, innovate and implement new ideas.  Broad knowledge and extensive experience in drug product development projects in various phases to facilitate efficient and successful implementation of projects.   Experience and training in supervision.    QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Hired, supervised and trained professional employees. Excellent interpersonal skills. Knowledge and application of regulations relating to supervising employees. Ability to work with scientific and operations personnel of customers and affiliates. Computer literate. Assist in the preparation and timely submission of ANDAs/NDAs, SOPs and other government filings. Presentation skills to technical personnel. Serve as technical resource.   PHYSICAL REQUIRMENTS: The employee is required to: Stand, walk, push, twist, reach overhead, and bend to the floor, Frequently move items up to 50 pounds and occasionally required to move items or objects up to 100 pounds, Occasionally required to climb ladders and/or steps to reach equipment. Visual Ability: Visual accommodation necessary for reading precision measuring equipment, machine dials, gauges, and thermometers; must be able to observe fine details under microscope; must be able to distinguish color indicator changes in test solution. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. Working Conditions: The employee is subject to: High noise levels from operating machinery Skin exposure to oils, vapors, and a variety of chemicals.  (Required to wear gloves when working with hazardous materials.) Breathing exposure to dust, mists, and fumes   COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments)

Quality Control Intern
Wed, 17 Apr 2013 20:07:52 GMT

Quality Control Intern JOB SUMMARY The essential job function is to help with any analytical preparatory requirements related to and and/or all physical and chemical testing of intermediate and finished products according to written procedures.        ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Perform weighing of intermediate and finished products in accordance with cGMP guidelines. Help to maintain laboratory equipment and keep work areas in good working condition. Perform assigned calibrations for equipment in the laboratory, as designated by supervisor. Help to review analytical reports and/or laboratory notebooks in accordance to cGMP’s. Observes all safety procedures and regulations. Other job-related tasks as required Attends work on a regular and predictable basis. Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. Work effectively under production and sales deadlines.   SUPERVISORY RESPONSIBILITY None       EDUCATION AND/OR EXPERIENCE Junior/Senior Level college student earning a degree towards Chemistry/Biological Sciences. Experience in an University/College Laboratory setting – HPLC/GC/Dissolution equipment. High degree of oral and written communication skills. Experience with Microsoft Word, Excel and Access a plus     QUALIFICATIONS         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Interfaces with other personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, and Quality Assurance. Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. Confidentiality required due to access to written procedures regarding manufacturing and testing of products.    GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks.  Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   PHYSICAL REQUIREMENTS: Physical Demands: The employee is required to: stand, walk, push, pull, twist, reach overhead, and bend to the floor occasionally move items or equipment weighing up to 100 pounds occasionally required to climb ladders and/or steps to reach equipment Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.           Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. Manual Dexterity :       Must have steady hands and good physical coordination in order to handle delicate laboratory         instrumentation and equipment. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed.   Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health.     COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Operator 1
Tue, 16 Apr 2013 16:58:12 GMT

Operator 1 This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).    

Manager, Market Research
Tue, 16 Apr 2013 15:30:59 GMT

MANAGER, MARKET RESEARCH JOB SUMMARY Reporting to the Director, Business Analytics, the primary responsibility of this position will include: product forecasting, data collection, market research design and implementation, and sales data analysis to help in the formulation of strategies for the company’s brands. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned as needed. Primary Market Research •  Lead the development and manage methodology behind primary qualitative/quantitative market research projects; •  Communicates research results to management and collaborates with brand teams to develop and implement strategies; •  Lead, develop, and manage market assessments for business development and LCM initiatives; •  Manage Market Research Budget for applicable products. Forecasting •  Develop and manage product forecasts based on statistical analysis, market modeling and sales/marketing strategies; •  Maintains forecast models on current products and ensures brand managers understand model assumptions; •  Establish, collaborate, and lead a cross functional team within the commercial organization for LBE, brand plan, and 5 year forecasts, and representative goal setting forecasts; •  Provide additional value and insights beyond integrating primary and secondary research; •  Consults Ex-US Forecasts for both Canada and Europe. Secondary Analytics •  Establishes and maintains databases for use in analyzing future marketing plans and forecasts while enhancing data collection sources (e.g. syndicated, domestic, international) to meet research objectives; •  Obtains external information from the market on competition/industry, localized plans and perceived impact on customers to develop 'best practice' approaches; •  Supervise national secondary data analytics as it pertains to monthly brand-performance; •  Design sub-national ROI analyses, interpret results, and provide recommendations for sales and marketing initiatives; •  Assists in Call Planning/targeting and other field force exercises; •  Manages sub-national ROI analyses on all non-personal promotion field force efforts. New Business Development •  Provide commercial assessments on business development opportunities for the US, EU5, and Canada:  co-promotions, acquisition of commercially available products, new product opportunities (phase II/III development), licensing opportunities, etc; •  Support development of life cycle management strategies, forecasts, and contribute to NPV analyses for new product formulations; •  Forecast revenues and analyze commercial capabilities of publicly traded companies. Other •  This position can be expected to exercise periodic supervisory responsibilities over junior members of the Department; •  Partner with marketing in development of strategic and tactical brand plans; •  Supervise and communicate quarterly estimates, annual budgets, national sales goals, and five year strategic forecasts to Aptalis Board of Directors for all promoted products. EDUCATION AND/OR EXPERIENCE •  BS/BA degree from a four-year accredited university or college, preferably in Business, Marketing, Economics, Finance or related field; •  Minimum of seven (7) years of related experience required and at least two (2) years in market interpretation and forecasting. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Proficient in Microsoft Office with advanced skills in Excel (Pivot tables, Vlookup, •  Macros, If Statements, Formulas), Access, PowerPoint and SQL; •  Working knowledge of physician data concepts (e.g. Rxs, patient visits) and how data collection techniques can be used to obtain knowledge within the area is essential; •  Demonstrated proficiency in identifying or modifying techniques for collection of pharmaceutical/ professional/payer information and how to apply data/consumer measurement concepts to increase validity and usefulness of data collected; •  Exhibits strong understanding of the types of methodologies required for various data collection efforts to translate research objectives into practice and communicate actionable recommendations; •  Displays thorough understanding of business environment and key drivers (e.g. financial concepts, profit and loss) to support market research decisions, recommendations, planning, and execution; •  Demonstrates high level of proficiency in obtaining information, effectively allocating and applying resources in the best manner to meet company and project objectives; •  Ability to interface effectively with multiple levels of management and cross-functionally; •  Results-oriented with a willingness to take on responsibility and initiative; •  Excellent interpersonal written and oral communication skills; •  Attends work on a regular and predictable basis; •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds all Company policies, including but not limited to, the Aptalis Code of Conduct and the Professional Conduct Policy and Prohibition Against Harassment Policy; •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public; •  Supports the Aptalis vision and mission and exemplifies Aptalis values; •  Able to prioritize duties and manage multiple projects from start to finish with minimal supervision; •  Exceptional attention to detail and excellent organizational skills; •  Ability to accommodate up to 25% travel.

Pharmaceutical Sales Specialist
Fri, 12 Apr 2013 14:42:03 GMT

PHARMACEUTICAL SALES SPECIALIST - BUFFALO JOB SUMMARY The Pharmaceutical Sales Specialist is responsible for managing the business of an assigned sales territory and meeting or exceeding sales objectives for that territory. This position makes day-to-day decisions on sales calls, territory management and administration, handling customer service issues and opportunities, and implementing marketing plans. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Creates call plans and makes effective in person sales calls on healthcare professionals and their staffs providing current, accurate, company-approved product information to physicians, nurses, pharmacists and other classes of customers. •  Makes judgments about the appropriate message for each healthcare provider, including decisions about which products to discuss, frequency of in person calls and which approved materials to use during the call. Prepares for sales calls in advance by planning specific objectives, including an effective opening. Assesses the practitioner’s individual needs, determines how the products can meet the practitioner’s needs, and positions the product features and patient and practitioner benefits to satisfy practitioner and patient needs.  Answers questions or objections, provides fair balance and closes by asking for the business. •  Decides what types of interactions and educational opportunities will maximize the prescribing of Aptalis products. Effectively executes sales tactics, including the building of relationships within the practitioner community, such as arranging breakfasts and lunches at medical offices, conducting speaker programs, supporting events and community outreach programs, and participating in key industry meetings. •  Analyzes data provided by Aptalis, prescribing trends, competition and provider habits to customize the sales tactics and strategy, thereby maximizing the effectiveness of each call. •  Formulates and implements strategies for increasing the sales and market share of products including participation in creative sessions as part of the Marketing Advisory Board Committee; formulates and prepares the market for new product launches, and implements new product launches. •  Develops creative techniques, within compliance guidelines, to overcome access challenges and bring products to customers' attention. •  Builds relationships with pharmacy directors at hospitals, market and trade relations, members of the Pharmacy and Therapeutics Committee, and influential members of the medical community and works with them to add Aptalis' products to the hospital formulary. •  Works with pharmacists to solve managed health care issues. •  Seeks out knowledge of competitive products and activities and uses such market intelligence to increase sales; provides feedback of market intelligence to Aptalis management, including evaluating and sharing competitor information. •  Identifies "Key Opinion Leader" physicians for Aptalis products to speak at promotional dinner programs, and helps to identify additional health care professionals to develop as Aptalis approved speakers. •  Completes Daily Call Reports, maintaining accurate and current records of physicians, clinics, customer in person calls and outlining achievements, observations, suggestions, needs and summaries of call objectives. •  Completes timely Prescription Drug Marketing Act (PDMA) sample reconciliation reports, itineraries, expense reports and other administrative reports; inventorying, maintaining and appropriately using samples according to Company policy. •  Employs safe driving techniques and maintains the Company car according to the Aptalis Fleet Service Guide. •  Prepares for, attends and actively participates in Company sales and training meetings, including initial sales training. •  Manages budget to maximize sales and accomplish goals while achieving the highest return on investment. •  Implements or participates in approved and compliant preceptorship programs. •  Researches, reads, and studies medical literature to improve product knowledge in order to increase sales effectiveness; dissects and summarizes technical scientific reprints on specialty issues and discusses the findings of company-approved clinical reprints with medical professionals. •  Works well with others, listens to and values others' opinions; meets all deadlines and responsibilities and helps Regional Sales Manager meet region’s goals; welcomes newcomers and promotes a team atmosphere. •  Applies the highest possible standard of business ethics and behaves consistently with the Company’s values; is widely trusted and seen as a direct, truthful individual; is regular and predictable in attendance; can present the truth in an appropriate and helpful manner by keeping confidences, admitting mistakes and does not misrepresent him/herself for personal gain. •  Effectively adapts when faced with changing situations, unexpected pressures, and varying job demands; understands and appreciates different and opposing perspectives on an issue; supports and manages change initiatives. •  Maintains a neat and professional appearance at all business functions. •  Attends to above duties and makes in person sales calls on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including but not limited to the Commercial Compliance Policy, Professional Conduct Policy and Prohibition Against Harassment Policy and the Business Ethics and Conduct Code, and displays a history of integrity and honestly. •  Must have the ability to complete an assigned task and in person sales call in a safe manner and in a constant state of alertness. •  Must be able to work in a cooperative manner with co-workers, supervisors, managers, doctors, health care workers and others. •  Works effectively under production and sales deadlines. SUPERVISOR RESPONSIBILITY This position has no supervisory responsibility. ESSENTIAL EDUCATION, EXPERIENCE, TECHNICAL SKILLS, AND QUALIFICATIONS Education and/or Experience •  Bachelor’s degree from four-year accredited college or university plus a minimum of two years pharmaceutical or related healthcare sales experience required.  Experience within the GI therapeutic specialty preferred. Essential Licenses, Certifications and Immunizations Possess a valid driver’s license in the Pharmaceutical Sales Specialist’s state of residence and maintain a driving record that is acceptable to the Company and its insurer. Must have required immunizations as mandated by various hospitals and medical clinics to enter their premises. Essential Working Conditions Ability to daily travel, including overnight travel, by air and / or automobile, through the assigned territory, work long hours when necessary and work away from home for extended periods, to call on Gastroenterologists, Colorectal Surgeons, and other Specialists and Hospitals as appropriate.  May include calling on cystic fibrosis centers and non-center CF specialists. Essential Qualifications •  Ability to meet and exceed sales goals, including the ability to formulate and successfully implement business plans, sales plans and sales calls. •  Ability to recognize internal and external customer needs and successfully position Aptalis Pharma products as solutions to customers’ needs. •  Ability to meet customer expectations and requirements on a timely basis. •  Ability to work independently and manage time effectively without close supervision. •  Must have the capability to make effective and persuasive speeches and presentations on complex topics to key audiences, i.e., physicians, caregivers and patients/parents. •  Proven ability to effectively interface and work cooperatively with individuals of all levels, plus demonstrated oral and written communication skills. •  Ability to think on his/her feet and adapt quickly to respond to physician's questions and various situations. •  The ability to occasionally lift 50-60 lbs. climb stairs, enter various types of medical related settings, safely operate an automobile and travel alone. •  Proficient in E-mail. Internet use, Microsoft Word, Excel and PowerPoint •  High attention to detail and accuracy, a commitment to quality work, and the ability to deploy strengths and compensate for weakness.

Analyst, FP&A - U.S. Specialty Pharma, Business Development and Legal
Thu, 11 Apr 2013 19:22:07 GMT

ANALYST, FINANCIAL PLANNING & ANALYSIS – U.S. SPECIALTY PHARMA, BUSINESS DEVELOPMENT (BD) AND LEGAL JOB SUMMARY Responsible for supporting assigned department managers in the decision making related to the financial aspects of the department. Participates in the development of the annual planning and contributes to upholding the financial health of the U.S. Sales Force, U.S. Sales Operations, Business Development and Legal areas. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Actively participates in the preparation of the annual plan (budget) and in the preparation of appropriate cost drivers with the assigned department managers. •  Carries out the monthly analysis of the budget and forecast variances. •  Participates in the preparation of the quarterly and revised annual forecasts (LBE). •  Develops and prepares relevant management reports in order to meet the needs of the assigned department managers. •  Prepares various communications presented to department managers. •  Provides monthly accruals for the U.S. Specialty Pharma, BD and Legal departments to accounting. •  Works with the assigned department managers in order to identify improvement opportunities related to the financial management of their projects. •  Stays up-to-date on the best practices in order to best advise the clients. •  Develops and maintains relationships within financial services and with other departments in order to ensure optimal exchange of information. •  Supports financial services with different demands of analysis related to the U.S. Specialty Pharma, BD and Legal departments. •  Participates in the preparation of documentation needed for tax credits. •  Provides monthly and quarterly financial reports as needed by the assigned departments. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds all Company policies, including but not limited to, the Aptalis Code of Conduct and the Professional Conduct Policy and Prohibition Against Harassment Policy. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Supports the Aptalis vision and mission and exemplifies Aptalis values. SUPERVISORY RESPONSIBILITIES None. EDUCATION AND/OR EXPERIENCE Bachelor degree in accounting or the equivalent together with a minimum of three (3) years of relevant experience. Must hold a relevant professional title: CMA, CPA, CGA and/or MBA. Experience in a pharmaceutical company is an asset. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, Vlookup, Macros, If Statements, Formulas) •  Experience working with an accounting program (Microsoft AX is an asset) •  Proficiency in Cognos TM1 a plus •  Excellent interpersonal written and oral communication skills •  Ability to advise managers and influence decisions •  Good knowledge of generally accepted accounting principles •  Ability to coordinate, contribute to and work within a cross-functional team •  Ability to thrive in a dynamic and fast-paced environment •  Able to prioritize duties and manage multiple projects from start to finish with minimal supervision •  Exceptional attention to detail and excellent organizational skills •  Possess the highest level of work ethics and integrity with the ability to maintain confidential information •  Proven problem solving skills including defining problems, collecting relevant data, establishing facts, drawing valid conclusions, and recommending improvement/corrective actions •  Resourceful, action and results-orientated with the ability to get things done and overcome obstacles  

Manager, Access & Reimbursement Services - North Atlantic
Thu, 04 Apr 2013 14:07:44 GMT

MANAGER, ACCESS & REIMBURSEMENT SERVICES (MARS) JOB SUMMARY The primary responsibility of the Manager, Access and Reimbursement Services is to achieve targeted payer access, optimal profitability, account development, and key product objectives for the full US corporate product portfolio.  This position will play a critical role in collaborating and organizing activities for a set of local market commercial teams to optimize its reimbursement environment in support of accomplishing key corporate goals. This position will cover New York City, NJ, CT, RI, MA, ME, NH and VT, require 50% travel, and be located near a major airport. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned.  Market  Access (Account Management) – 40%: •  Works closely with key decision makers and the processes that govern the reimbursement of Aptalis products at:      Regional payers (commercial, Medicare Part D and Medicaid);      Assigned state Medicaid FFS Programs and Exchanges;      Prioritized health systems (including integrated delivery systems, multispecialty group practices);      Other emerging customer segments (as identified by Managed Markets Leadership) •  Develops an annual payer/business Account Management plan with specific tactics for each assigned account across all prioritized Aptalis products. This includes SMART brand performance objectives and account face-to-face frequency objectives. •  Works closely with Manager, Payer Analytics to provide an annual forecast of projected sales and trends for each assigned account. •  Works closely with Medical Information and Medical Affairs to identify and address each assigned account’s evidence requirements for a positive clinical review of each Aptalis product. •  Actively works with assigned accounts to reduce prescribing barriers and patient OOP (Out of Pocket) burden to ensure appropriate access to and utilization of key products in targeted profitability ranges. •  Ensures continuous evaluation and prioritization of payer and institutional business to ensure optimal profitability. •  Interprets and integrates complex data to optimize key payer and institution opportunities across the assigned area. •  Keeps current on processes, filing requirements and timelines for new product market entries. Pull Through – 30%: •  Expectation of up to daily interaction with Managed Markets Corporate Accounts colleague(s) for bi-lateral information and best practices exchange relative to local market pull-through of prioritized corporate accounts. (Note: for those sub-national accounts under own management, a similar outreach effort will be required and will be overseen by the Director, Market Access). •  Assists the local commercial teams in driving sales, market share, thought leader development, and balancing of the profit equation. Will have aligned incentives based on  account and Sales geography overlay. •  Advises on optimal call plan targets (using Managed Markets decision support tools), tailored market access messaging and the use of approved patient support programs and tactics along with local Sales management to achieve sales objectives and gross to net objectives within Aptalis contracted accounts.  •  Interacts with Sales counterparts and acts as lead for all pull through efforts in assigned area including key state FFS & Managed Medicaid, commercial payer, and Medicare Part D initiatives. •  Interacts with Sales counterparts including a regular and active role at all meetings, regular field rides and ad hoc support of institutional formulary access initiatives. •  Actively engaged with Sales colleagues to identify prescribing barriers related to reimbursement in assigned area. •  Facilitates alignment with matrix (field and office) team members to ensure successful execution of product pull through plans •  Plays a key role in translating strategy into geographic region and payer segment specific goals, objectives, and plans and then successfully executing and achieving them. Reimbursement Services – 20%: •  Accountable for collaboratively developing and communicating commercial team’s local market reimbursement tactical plan for key products using available and PARC approved tools. •  In close collaboration with MM leadership and internal contracting/analytics team, Negotiates and implements high performance contracts that; achieve optimal patient OOP, support brand strategies and manage profitability margins. •  Works closely with internal contracting and analytics team members throughout the full contract life-cycle (including the pre-deal phase). •  Performs customer contract reviews at appropriate intervals to monitor progress. •  Develops a strong understanding and regularly communicates to local commercial team the Aptalis reimbursement value proposition as it relates to local managed market trends, benefit designs, health system consolidations and individual payers. Miscellaneous Duties – 10%: •  Expected to maintain a minimum of level 1 proficiency and regularly pursue ongoing improvement of the Managed Markets competencies specific to the MARS role. •  Provides key inputs into the monthly Managed Markets metrics reporting. •  Expected to meet all administrative expectations such as expense reporting, customer contact summaries, record keeping, business planning, calendar planning, etc. •  Work closely with all corporate team members and accomplish directed goals cross functionally •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY This job has no supervisory responsibility. EDUCATION AND/OR EXPERIENCE Requirements include the following: •  BS/BA degree from a four-year accredited university or college; MBA preferred; •  a minimum of five (5) years of demonstrated experience and proven success in biotech/ pharmaceutical industry; •  (For internal candidates) a minimum of two (2) years experience in institutional sales, sales management, reimbursement, contract strategy, managed care sales, marketing, Medicaid, VA/Military, or account management •  (For external candidates) a minimum of five (5) years experience in institutional sales, sales management, reimbursement, contract strategy, managed care sales, marketing, Medicaid, VA/Military, or account management QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Must possess thorough knowledge of US healthcare system (including federal, state and local programs) •  Excellent presentation skills and the ability to assimilate and analyze diverse data to develop tactical action steps to achieve sales results. •  Must possess strong leadership and selling skills to maximize performance results of the organization. •  Proficient in Microsoft Office, and strong understanding of pharmaceutical data sets and integration tools. •  Exceptional attention to detail and excellent organizational skills. •  Ability to identify the critical issues or opportunities using appropriate information and solve or elevate issues according to reach and severity •  Ability to prioritize responsibilities to meet regular and critical deadlines. •  Ability to contribute to and work within a cross-functional team. •  Excellent verbal and written communication and presentation skills. •  Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. •  Ability to thrive in a dynamic and fast-paced environment. •  Demonstrated ability to clearly and accurately interpret and follow procedures and policies. •  Ability to accommodate 50% travel.

Manager, Access & Reimbursement Services - Upper Mid-Atlantic
Thu, 04 Apr 2013 14:05:58 GMT

MANAGER, ACCESS & REIMBURSEMENT SERVICES (MARS) JOB SUMMARY The primary responsibility of the Manager, Access and Reimbursement Services is to achieve targeted payer access, optimal profitability, account development, and key product objectives for the full US corporate product portfolio.  This position will play a critical role in collaborating and organizing activities for a set of local market commercial teams to optimize its reimbursement environment in support of accomplishing key corporate goals. This position will cover East VA, DC, MD, PA, Eastern OH and NY (except New York City) and will require approximately 50% travel.  This position should be located in Pittsburgh, Philadelphia, or near a major airport. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned.  Market  Access (Account Management) – 40%: •  Works closely with key decision makers and the processes that govern the reimbursement of Aptalis products at:      Regional payers (commercial, Medicare Part D and Medicaid);      Assigned state Medicaid FFS Programs and Exchanges;      Prioritized health systems (including integrated delivery systems, multispecialty group practices);      Other emerging customer segments (as identified by Managed Markets Leadership) •  Develops an annual payer/business Account Management plan with specific tactics for each assigned account across all prioritized Aptalis products. This includes SMART brand performance objectives and account face-to-face frequency objectives. •  Works closely with Manager, Payer Analytics to provide an annual forecast of projected sales and trends for each assigned account. •  Works closely with Medical Information and Medical Affairs to identify and address each assigned account’s evidence requirements for a positive clinical review of each Aptalis product. •  Actively works with assigned accounts to reduce prescribing barriers and patient OOP (Out of Pocket) burden to ensure appropriate access to and utilization of key products in targeted profitability ranges. •  Ensures continuous evaluation and prioritization of payer and institutional business to ensure optimal profitability. •  Interprets and integrates complex data to optimize key payer and institution opportunities across the assigned area. •  Keeps current on processes, filing requirements and timelines for new product market entries. Pull Through – 30%: •  Expectation of up to daily interaction with Managed Markets Corporate Accounts colleague(s) for bi-lateral information and best practices exchange relative to local market pull-through of prioritized corporate accounts. (Note: for those sub-national accounts under own management, a similar outreach effort will be required and will be overseen by the Director, Market Access). •  Assists the local commercial teams in driving sales, market share, thought leader development, and balancing of the profit equation. Will have aligned incentives based on  account and Sales geography overlay. •  Advises on optimal call plan targets (using Managed Markets decision support tools), tailored market access messaging and the use of approved patient support programs and tactics along with local Sales management to achieve sales objectives and gross to net objectives within Aptalis contracted accounts.  •  Interacts with Sales counterparts and acts as lead for all pull through efforts in assigned area including key state FFS & Managed Medicaid, commercial payer, and Medicare Part D initiatives. •  Interacts with Sales counterparts including a regular and active role at all meetings, regular field rides and ad hoc support of institutional formulary access initiatives. •  Actively engaged with Sales colleagues to identify prescribing barriers related to reimbursement in assigned area. •  Facilitates alignment with matrix (field and office) team members to ensure successful execution of product pull through plans •  Plays a key role in translating strategy into geographic region and payer segment specific goals, objectives, and plans and then successfully executing and achieving them. Reimbursement Services – 20%: •  Accountable for collaboratively developing and communicating commercial team’s local market reimbursement tactical plan for key products using available and PARC approved tools. •  In close collaboration with MM leadership and internal contracting/analytics team, Negotiates and implements high performance contracts that; achieve optimal patient OOP, support brand strategies and manage profitability margins. •  Works closely with internal contracting and analytics team members throughout the full contract life-cycle (including the pre-deal phase). •  Performs customer contract reviews at appropriate intervals to monitor progress. •  Develops a strong understanding and regularly communicates to local commercial team the Aptalis reimbursement value proposition as it relates to local managed market trends, benefit designs, health system consolidations and individual payers. Miscellaneous Duties – 10%: •  Expected to maintain a minimum of level 1 proficiency and regularly pursue ongoing improvement of the Managed Markets competencies specific to the MARS role. •  Provides key inputs into the monthly Managed Markets metrics reporting. •  Expected to meet all administrative expectations such as expense reporting, customer contact summaries, record keeping, business planning, calendar planning, etc. •  Work closely with all corporate team members and accomplish directed goals cross functionally •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY This job has no supervisory responsibility. EDUCATION AND/OR EXPERIENCE Requirements include the following: •  BS/BA degree from a four-year accredited university or college; MBA preferred; •  a minimum of five (5) years of demonstrated experience and proven success in biotech/ pharmaceutical industry; •  (For internal candidates) a minimum of two (2) years experience in institutional sales, sales management, reimbursement, contract strategy, managed care sales, marketing, Medicaid, VA/Military, or account management •  (For external candidates) a minimum of five (5) years experience in institutional sales, sales management, reimbursement, contract strategy, managed care sales, marketing, Medicaid, VA/Military, or account management QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Must possess thorough knowledge of US healthcare system (including federal, state and local programs) •  Excellent presentation skills and the ability to assimilate and analyze diverse data to develop tactical action steps to achieve sales results. •  Must possess strong leadership and selling skills to maximize performance results of the organization. •  Proficient in Microsoft Office, and strong understanding of pharmaceutical data sets and integration tools. •  Exceptional attention to detail and excellent organizational skills. •  Ability to identify the critical issues or opportunities using appropriate information and solve or elevate issues according to reach and severity •  Ability to prioritize responsibilities to meet regular and critical deadlines. •  Ability to contribute to and work within a cross-functional team. •  Excellent verbal and written communication and presentation skills. •  Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. •  Ability to thrive in a dynamic and fast-paced environment. •  Demonstrated ability to clearly and accurately interpret and follow procedures and policies. •  Ability to accommodate 50% travel.

Alliance Manager
Thu, 04 Apr 2013 12:10:12 GMT

ALLIANCE MANAGER   JOB SUMMARY: The primary role of the Alliance Manager will be to support the Pharmaceutical Technologies (PT) business by working with internal PT Licensing, Finance, Legal, Operations, Supply Chain and R&D functions to ensure Aptalis’s PT co-development partner relationships are managed appropriately and within Aptalis’s accepted business practices.  The Alliance Manager will be tasked to use and implement Aptalis’s Alliance Management Best Practices that will provide the process by which we work with customers.  The Alliance Manager will also conduct certain financial analysis on PT co-development projects, provide budgeting and forecast information to the PT business, and will be required to make presentations to Aptalis PT internal and external customers.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. The Alliance Manager performs the following activities: •  Provide co-development customers with a single point of contact. •  Coordinate communication between internal functions and Customers. •  Evaluate collaborative success through alliance questionnaires and provide recommendations for improvement. •  Liaise with internal (R&D, Quality, Finance, etc), and external functions (CROs, vendors, etc.). •  Manage projects and ensure contractual obligations  are met – internal and external. •  Manage fee and milestone payments, and related forecasts. •  Negotiate amendments to contracts, fee adjustments and follow-up projects. •  Prepare and maintain financial forecasts. •  Provide recommendations to improve the Alliance Management Best Practices Policy to ensure consistent global management of R&D contacts, requests, and contract execution. •  Proactively handle arising governance issues related to contractual and project matters, internally and externally. •  Manage clients and contacts through the Customer Relationship Management (CRM) system. •  Ensure provisions of the development agreements and licenses are implemented. •  Liaise with legal, PT members and other functions to ensure that timelines are achieved.   GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: None.   TRAVEL REQUIRED: •  20% US •  5% International   EDUCATION AND/OR EXPERIENCE: •  Bachelor’s degree in a life sciences related discipline. •  An MBA or MS a plus but not a requirement. •  A minimum of 4 years of progressive experience in R&D, business development, project management, quality, and/or similar form of customer service oriented activity in the pharmaceutical industry. •  Knowledge of the pharmaceutical development and manufacturing processes for solid oral dose products.   QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Experience in contract negotiations. •  Energetic, entrepreneurial and passionate about their work and opportunity to contribute to the growth and success of the company. •  Solid presentation skills, both verbal and written English, including the ability to effectively and succinctly communicate complex concepts. •  General proficiency in MS Office Professional products. •  Adept at influencing others and participating on cross-functional teams.   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments)

Sr. Manager, Third Party Manufacturing
Thu, 28 Mar 2013 19:10:00 GMT

SENIOR MANAGER, THIRD PARTY MANUFACTURING   JOB SUMMARY : The Senior Manager, Third Party Manufacturing - Specialty Product is responsible to manage all outsourced manufacturing activities. This position reviews supplier performance and administrate continuous improvement programs. This position ensures accountability for supplier performance and continuity of supply by maintaining partnerships.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES : The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Oversees and Manages the contract manufacturers used by the company for the supply of certain specialty products. •  Maintains strategic alliances and partnering and adherence to supply agreements  and is responsible for management of those agreements. •  Works with Global Sourcing to participate in the contract negotiation, amendments for same. Manages supply contracts, suppliers relationships and supplier performance analysis. •  Participates for development and implementation of risk management strategies for the company’s third party product supply chain; including product supply, vendor performance.  •  Conducts assessment of risks related to suppliers, at planned frequency. •  Ensures technical services needs are addressed to support third party product supply.  •  Manages supplier management programs and performance metrics, ensures an uninterrupted supply of required materials and works to eliminate inefficiencies and minimize transactional processing and associated costs by utilizing automation, rationalization and consolidation. •  Directs and  influences third party manufacturers to identify and implement cost savings and process improvements. •  Implements appropriate metrics for management of third party production including KPIs and monitors performance. •  Actively seeks appropriate cost reductions in the third party manufacturing  networks whilst maintaining required compliance standards and business practices. •  Ensures continuing compliance of the company’s third party manufacturers with relevant company requirements. •  Evaluates third party site audit findings and responds to these findings with globally-aligned process and procedure improvements that drive system compliance, efficiency and effectiveness. •  Buyer Planning Activities •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines.   GENERAL REQUIREMENTS : All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY : None.   EDUCATION AND/OR EXPERIENCE : Bachelor’s degree in Commerce, Science, Engineering or equivalent, combined with a minimum of seven (7) years of strong business experience in the pharmaceutical industry or similar industry, with Third Party manufacturing experience.   QUALIFICATIONS :  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  ERP systmes experience, SAP preferred. •  Working knowledge of Canadian, American and European good manufacturing practices (GMP). Knowledge of other GMP systems (e.g, PIC) •  Knowledge of pharmaceutical dosage form manufacturing techniques, processes and quality systems. •  Knowledge of pharmaceutical product distribution channels and regulations. •  Extensive  knowledge of quality assurance and compliance techniques and procedures. •  Operational knowledge of Canadian, American and European regulations. •  Operating knowledge of Lean Manufacturing, Total Quality Management systems. •  Proficiency in implementing management procedures, standards, programs and concepts in a global scope. •  Experience in cross-functional team and project management. •  Ability to develop and implement quality management tools. •  Ability to recognize people skills and a proven track record in personnel development. •  Ability to organize and manage the work of department employees. •  Excellent written and oral communication skills with the Company’s various internal and external stakeholders. •  A spirit of integration and analysis. •  Ability to work under pressure. •  Quality of judgment and evaluation of situations. •  Business sense. •  Ability to adapt to a rapidly changing environment. •  Excellent knowledge of sourcing tools such as spend analytics, e-Sourcing, p-cards. •  Ability to travel 10-20% of the time.  Domestic and International.   PHYSICAL REQUIREMENTS: The employee is required to: •  Stand, walk, push, pull, twist, reach overhead, and bend to the floor 1. Visual Requirements: •  Must have visual capability for reading written instructions and computer monitors.   COMPANY POSITION STATEMENT : This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Human Resources Coordinator
Tue, 26 Mar 2013 15:41:42 GMT

HUMAN RESOURCES COORDINATOR JOB SUMMARY The Human Resources Coordinator provides administrative, organizational and project management support to the HR department including the VP, HR – North America, Sr. Director, Organizational Development and Talent Management and Sr. HR Manager, BDW. Duties include project management of key HR initiatives and programs, responding to and routing employee inquiries, assisting with correspondence, document preparation and filing, invoice/expense reporting, invoice payments, travel arrangements, coordinating meetings, events, conference calls, planning and organization of work, follow-up communications as required, and assistance with special projects.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Works with Sr. Director, Organizational Development and Talent Management and VP, HR to plan, organize, project manage and track timelines and progress of key HR initiatives and activities, e.g., Employee Survey, Performance Management process, Succession Planning, special projects, etc., including follow up with stakeholders and reporting. •  Responds to employee inquiries about HR policies and procedures and routes questions to appropriate sources as necessary. •  Provides administrative support in a variety of capacities including processing incoming mail, initiating telecommunications, document filing, copying, faxing, and invoice/expense reporting. •  Maintains managers’ appointments and schedules, greets guests, plans/arranges events and meetings as well as the registration to conferences.  •  Manages telephone calls for managers from both internal and external sources.  Screens incoming calls and correspondence and responds independently when possible. •  Follows-up on pending matters, such as comments to be received, answers to be given, and answers or signatures to be received (letters, agreements, contracts, etc.). •  Works in financial software to establish new vendors, and enter budget codes, contract data and invoices. •  Assists in scheduled conferences and meetings, writes the minutes of meetings and ensures follow-up on discussed subjects. •  Prepares correspondence from draft stage to client-ready work and distributes as needed. •  Updates and maintains Outlook contacts. •  Acts as a liaison between members of the HR department to facilitate work and accomplish objectives in a collaborative effort. •  Organizes and maintains the department filing systems. •  Processes expense reimbursements in expense reporting system. •  Maintains confidences and protects operations by keeping information confidential. •  Performs special projects as assigned. •  Assists in preparing Word Document, PowerPoint presentations and maintaining Excel spreadsheets. •  Provides backup for receptionist as needed. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Promotes the Company’s Mission and Vision. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE Bachelor’s Degree is preferred plus three to five (3-5) years’ relevant experience or High school diploma plus a minimum of seven (7) years’ relevant experience is required. Experience working in HR is preferred. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Must possess the highest level of work ethics and integrity with the ability to maintain confidentiality of information.  •  Possess strong administrative and organizational skills with the ability to take initiative to complete assignments and job responsibilities with minimal supervision. •  Able to prioritize duties and contribute to multiple projects; including projects that are cross-functional and global. •  The individual must be able to effectively interface with a variety of people and work well under stressful situations. •  Must have excellent grammar and telephone etiquette and above average ability to interface with people using tact and diplomacy. •  Proficient in Microsoft Word, Excel and PowerPoint. Must be able to format a Word Document to perfection. •  Must possess good working knowledge of office equipment including voice mail system, multi-line telephone and facsimile. Must also demonstrate and embody the COMPANY’S CORE BEHAVIORS : •  Customer Focused: Dedicated to meeting expectations and requirements of internal and external customers •  Innovation: Encourages and applies creativity; has good judgment about which creative ideas and suggestions will be effective •  Compassion: Genuinely cares about people; takes time to listen and provides support •  Interdependence: Is an effective team player who adds complementary skills and contributes valuable ideas, opinions and feedback •  People Focused: Understands the importance of personal development and growth; keeps knowledge and skills up to date and supports development of others •  Results Driven : Maximizes use of resources, sets challenging goals and prioritizes to deliver results •  Integrity: Applies highest possible standard of business ethics; is widely trusted and seen as a truthful individual

Director, Clinical Pharmacology
Fri, 22 Mar 2013 18:30:47 GMT

DIRECTOR, CLINICAL PHARMACOLOGY JOB SUMMARY This is a newly created scientific and medical leadership position within the Pharmaceutical Technologies organization reporting directly to the Chief Research Officer. The successful applicant for position of Director, Clinical Pharmacology will design and lead the clinical development of all drug products in the Pharmaceutical Technologies new-product portfolio from concept through clinical testing and submission CHIEF RESPONSIBILITIES The Director, Clinical Pharmacology will design, conduct, analyze, interpret, and report human safety, pharmacokinetic, proof-of-concept, and therapeutic bioequivalence studies and contribute to the design, analysis and interpretation of preclinical efficacy and safety pharmacology and toxicology studies. All animal and human studies will be conducted in partnership with outside vendors (CROs) offering an opportunity for the candidate to select and direct the research efforts of high-performance research centers around the world. A critical and unique component of this position, is the opportunity and challenge for the incumbent to identify unmet medical needs with existing drugs, ideate new-product opportunities, and champion the internal funding of new-product candidate development across multiple therapeutic areas. Accordingly, the successful applicant will possess highly relevant medical/clinical experience in drug-product development, along with the knowledge, skills, and desire to interact with medical opinion leaders, scientific advisors, and senior scientific- and business-function stakeholders within and outside the company. In addition to the major responsibilities, the Director will assist in preparation and review of bio-analytical plans, protocols and reports, act as subject-matter expert for company-wide projects and initiatives (e.g. SOPs), and contribute to various lifecycle management and marketing initiatives. ESSENTIAL SKILLS •  Substantial experience designing, conducting and interpreting clinical pharmacology studies, ideally in more than one therapeutic area in an industrial (ideally) or academic setting; •  Expertise with PK/PD data analyses, in-vitro and in-vivo correlation, nonlinear PK modeling, and biopharmaceutics/bioanalysis, and biomarker development; •  Experience filing successful investigational new-drug and related clinical trial authorization applications with regulatory authorities in the ICH territories; •  Confidence, willingness, and ability to represent the Clinical Pharmacology function on multi-disciplinary project teams, providing scientific advice and contributing to strategic discussions. SUPERVISORY RESPONSIBILITY No direct reporting relationships. The position requires leadership and influence skills to work effectively in a collaborative environment. EDUCATION AND/OR EXPERIENCE •  M.D. (or equivalent) with subspecialty training and accreditation in Clinical Pharmacology is preferred. A non-M.D. with a graduate degree in pharmacology/pharmacokinetics and post-graduate training in clinical pharmacology will also be considered. •  At least 10 years of experience designing and executing clinical pharmacology studies, including bioequivalence studies. •  Experience contracting and collaborating with CROs on global clinical studies. QUALIFICATIONS •  Possess a thorough knowledge of drug development processes, regulations, and guidelines particularly those governing first-in-human and therapeutic bioequivalence studies; •  Possesses in-depth knowledge of medical therapies and unmet needs in at least one therapeutic area and working knowledge in multiple areas; •  Has the demonstrated ability to work well in multidisciplinary teams and to plan work to meet deadlines and effectively handle competing priorities; •  Possess excellent verbal and written communication skills in English, including formal presentation skills; •  Has the demonstrated ability to influence, negotiate and collaborate with internal and external customers; •  Is proficient with Microsoft Office Suite (or similar productivity software) and specialty software for pharmacokinetic and pharmacodynamic trial design and analysis; •  Is willing and able to travel up to 15% annually (international and domestic).  

Director, Compliance - Policies, Training & Communications
Fri, 08 Mar 2013 20:40:52 GMT

DIRECTOR, COMPLIANCE - POLICIES, TRAINING & COMMUNICATIONS JOB SUMMARY The Director of Compliance – Policies, Training & Communications assists the Vice President, Chief Compliance Officer (CCO) in developing, implementing and maintaining a robust, dynamic and effective Corporate Compliance Program (CCP) that is designed and operates to: 1.  support and promote a company-wide culture of ethics and compliance; 2.  ensure the company’s compliance with both the letter and the spirit of all applicable federal and state health care laws and regulations, and industry codes of conduct; and   3.  match or exceed the standards set forth in the U.S. Sentencing Guidelines and 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers. This position is primarily responsible for the development and implementation of the Annual Compliance Plan, compliance policies, training programs and communications. As a member of a collaborative team, this position also will contribute to the development and implementation of other components of the compliance program. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned.  Reasonable accommodations may be made to enable individuals with disabilities to perform these duties and responsibilities. •  Assists the CCO in preparing the Annual Compliance Plan based upon a comprehensive , annual compliance risk assessment of relevant functional areas of the company. •  Assists the CCO in preparing reports to the Compliance Committee of the Board of Directors and otherwise executing the responsibilities of the Compliance Committee and CCO set forth in the Compliance Committee Charter. •  Assists the CCO in developing and executing the agenda, meetings and responsibilities of the company’s Compliance Committee. •  Maintains the company’s Codes of Conduct, for the U.S., Canada and the European Union, and updates the Codes as and when appropriate. Supervises the annual employee certification to the Codes. •  Develops, revises, updates and maintains compliance policies, procedures and instructions.   Collaborates with other departments of the company in addressing their policies, etc. relating to or impacting the company’s health care compliance.  Represents the Department on the Policy Committee. •  Assists the CCO in the development of health care compliance training for delivery to the Board of Directors and Management Team of the company. •  Develops, implements, tracks and measures employee training on all compliance policies, applicable laws, regulations and industry developments impacting the company’s health care compliance. Determines the appropriate vehicles for the delivery of such training, whether in-person, on-line, electronically or otherwise.  •  Develops and implements the compliance component of new employee orientation  and initial sales training, collaborating with relevant other departments of the company to do so. •  Develops and delivers compliance training at company and departmental meetings, including the national sales meeting and sales managers meetings.    •  Develops, maintains and publicizes the Department’s home page on the company intranet.  Develops the compliance component of the company’s internet website. •  Develops and implements tools for the communication of compliance principles, concerns and developments to company employees, and delivery of responses to compliance inquiries. •  Provides compliance guidance in response to employee inquiries. •  Reviews, analyzes and reports upon compliance and enforcement trends in the industry, as expressed, e.g., in reported CIAs and prosecutions.  Considers implications for the company and proposes and initiates proactive measures to address those implications. ADDITIONAL EXPECTATIONS •  Maintains an up-to-date knowledge and understanding of federal, state and international laws and regulations, industry codes of conduct and developments, and best practices that are relevant to or may impact the structure or operation of the Compliance Department and Program or may have a bearing on the company’s policies, practices or operations. SUPERVISORY RESPONSIBILITIES This position can be expected to exercise periodic supervisory responsibilities over junior members of the Department. EDUCATION AND EXPERIENCE •  Bachelors degree required.  Advanced degree, e.g. J.D., Masters, PhD, etc., favorably considered. •  Minimum of five (5) years experience in the pharmaceutical industry and three (3) years experience in a pharmaceutical manufacturing health care compliance program with relevant training and communications experience. QUALIFICATIONS The person performing in this position is expected to possess the following qualifications: •  A high sense of ethics and integrity. •  Independence, initiative, motivation and leadership by example and persuasion. •  Sound judgment, knowledge of the pharmaceutical industry, common sense and practicality. •  Strong interpersonal skills and collaborative ability. •  The ability to successfully juggle multiple projects in a timely and effective manner. •  The ability to work under pressure and meet deadlines. •  The ability to communicate, orally and in writing, effectively and persuasively. •  Creativity. •  The ability to travel, approximately 10 - 15% of working time.

Director, Compliance - Auditing, Monitoring & Reporting
Fri, 08 Mar 2013 20:40:20 GMT

DIRECTOR, COMPLIANCE - AUDITING, MONITORING AND REPORTING JOB SUMMARY The Director of Compliance – Auditing, Monitoring and Reporting assists the Vice President, Chief Compliance Officer (CCO) in developing, implementing and maintaining a robust, dynamic and effective Corporate Compliance Program (CCP) that is designed and operates to: 1.  support and promote a company-wide culture of ethics and compliance; 2.  ensure the company’s compliance with both the letter and the spirit of all applicable federal and state health care laws and regulations, and industry codes of conduct; and   3.  match or exceed the standards set forth in the U.S. Sentencing Guidelines and 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers. This position is primarily responsible for developing and implementing the Department’s  compliance auditing and monitoring programs, investigation procedures and disciplinary processes, conducting investigations and taking appropriate corrective action, and preparing and delivering required federal and state reports. As a member of a collaborative team, this position also will contribute to the development and implementation of other components of the compliance program. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Performs periodic gap analyses, process reviews and data analyses to identify and address opportunities to enhance the company’s compliance through its policies, processes and procedures. •  Develops and implements an annual auditing plan to effectuate the annual risk assessment.  Conducts compliance audits in accordance with the plan. •  Monitors company functions and activities for potential violations of law, regulation, industry codes, the company’s Code of Conduct and company policies.  •  Develops and implements a field monitoring program  Conducts field monitoring visits in support of the program. •  Develops and implements procedures for conducting compliance investigations.  Conducts investigations in accordance with those procedures. •  Develops and implements procedures for addressing potential or actual instances of non-compliance, undertaking appropriate corrective action where warranted.  Adopts preventative measures to limit or prevent the recurrence of non-compliance behavior and, where appropriate, reports such behavior to relevant government authorities.  Where appropriate, assists the CCO in  preparing reports of non-compliance to the government. •  Manages the company’s confidential ethics and compliance hotline for the reporting of compliance concerns or suspected compliance violations. Ensures that all hotline reports are responded to in a timely manner.  Publicizes the availability of the hotline to employees.  Tracks and manages hotline reports and responses.  Ensures that employees who make appropriately reports to the hotline incur no retaliation. •  Provides compliance guidance in response to employee inquiries. •  Oversees the preparation and timely submission of accurate and complete federal and state transparency and sample reports.  Develops, revises, updates and maintains the appropriate compliance policies and procedures in support of  the reporting process. ADDITIONAL EXPECTATIONS •  Maintains an up-to-date knowledge and understanding of federal, state and international laws and regulations, industry codes of conduct and developments, and best practices that are relevant to or may impact the structure or operation of the Compliance Department and Program or may have a bearing on the company’s policies, practices or operations. SUPERVISORY RESPONSIBILITIES This position can be expected to exercise periodic supervisory responsibilities over junior members of the Department. EDUCATION AND EXPERIENCE •  Bachelors degree required.  Advanced degree, e.g. J.D., Masters, PhD, etc., favorably considered. •  Minimum of five (5) years experience in the pharmaceutical industry and three (3) years experience in a pharmaceutical manufacturing health care compliance program with relevant auditing, monitoring, investigatory and reporting experience. QUALIFICATIONS The person performing in this position is expected to possess the following qualifications: •  A high sense of ethics and integrity. •  Independence, initiative, motivation and leadership by example and persuasion. •  Sound judgment, knowledge of the pharmaceutical industry, common sense and practicality. •  Strong interpersonal skills and collaborative ability. •  The ability to successfully juggle multiple projects in a timely and effective manner. •  The ability to work under pressure and meet deadlines. •  The ability to communicate, orally and in writing, effectively and persuasively. •  An awareness and sensitivity to the impact of their auditing, monitoring, investigatory and disciplinary programs and activities. •  The ability to travel, approximately 10 – 15% of working time.

Associate Director, Reimbursement Services - Managed Markets
Tue, 26 Feb 2013 21:08:45 GMT

ASSOCIATE DIRECTOR, REIMBURSEMENT SERVICES - MANAGED MARKETS JOB SUMMARY The primary responsibility of this position is to oversee the Company’s compliance with government purchasing program regulations and requirements, government contract management, government pricing reporting and collective gross-to-net (GTN) management for all contracts made with Managed Markets accounts, State Medicaid agencies, and vendors. This position is responsible for managing the day-to-day actions of the primary and support roles of the Reimbursement Services team, the optimal use of the Aptalis Revenue Management System and timely and accurate analytic contributions to the Board, Management Team, Finance, Sales, Marketing and the Managed Markets Field Organization. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Government Programs Administration (40%) •  Assures timeliness and accuracy of the administration of government rebate programs. •  Manages the optimal use of the government pricing system within Model N by the Team. •  Oversees the development and management a Class of Trade and eligibility system. •  Oversees the administration of the Federal Supply Schedule contract with the Department of Veterans Affairs (VA). •  Works closely with Federal and Account Managers in identifying opportunities and managing sales activity and contracts in government programs (State and Federal). •  Researches and develops plans for administration and management of any new government programs and/or contracts (i.e. blanket purchase agreements, prime vendor programs, or sub-ceiling PHS direct hospital pricing). •  Develops and monitors standard operating procedures (SOPs) and technical operating procedures (TOPs) governing pricing and contracting practices. Reviews SOPs and TOPs at least annually to ensure they reflect current business practices and good compliance habits. •  Acts as government pricing internal consultant for proposed programs to Managed Markets, Business Development, Marketing and Trade.           •  Conducts regular performance assessment of Team to assure a high level of audit readiness. Insulates the Company from needless exposure by working with outside counsel and consultants to design, implement and maintain an audit preparedness program. •  Enforces records management of the entire functional area, subject to approved records retention schedules and all applicable hold-orders. •  Oversees the Manager, Government Contract’s effective implementation of the Internal Proposal Process •  Maintains state of the industry professional knowledge of the latest legislation and guidance. Works closely with Legal, Finance, compliance groups, and outside consultants to address mandated changes.  Reimbursement Services (40%) •  Responsible for the overall coordination, execution and ongoing management of the Company’s patient out of pocket strategy. This includes cross functional coordination with Brand leads and vendors to align annual co-pay assistance programs and reimbursement initiatives. •  Works with Managed Markets leadership team to develop reimbursement services solutions for issues and opportunities at the client level and is specifically accountable for support to the department’s understanding of the reimbursement environment (benefit design changes, government program implications). •  Manages the development of internal methods as well as customer facing tools that will result in more accurate customer profitability assessment, decision-making for contracting and positive negotiation outcomes. •  Assists Marketing in communicating overall Aptalis and individual Brand reimbursement support to healthcare providers, caregivers and patients. •  Reviews market competitors and develop strategies to assure competitive out-of-pocket positioning for Aptalis Brands. •  Updates and delivers an annual training module to Commercial Team on reimbursement and benefit design trends, government pricing changes and competitive activities. Business Analysis/Reporting/Chargebacks (20%) •  Acts as lead for US Specialty Pharma’s Pricing Committee analytics. Develops a standardized decision support methodology to assure pricing and contract strategy proposals are fully vetted against government program risks. •  Oversees the Managed Markets data systems, reporting, and related processes. •  Ensures that the team makes meaningful contributions to the growth of the business through government program performance analytics. •  Accountable for the optimal use of the Aptalis Revenue Management System by the Reimbursement Services Team. •  Manages the timely and accurate daily processing of chargebacks. •  Ensuring proper processing of chargebacks per contract and/or policies; SUPERVISORY RESPONSIBILITY Produces value-added results through effective recruitment, delegation, performance management, training and development of employees in the following positions: •  Manager, Government Contracts •  Manager, Market Analytics •  Analyst, Government Reimbursement EDUCATION AND/OR EXPERIENCE Requirements include a Bachelor’s degree from an accredited university or college; a degree in Accounting, Finance or Computer Science is preferred. Additionally, a minimum of 10 years related experience including five (5) years of manager level experience in government contract administration, reimbursement services and/or reimbursement support programs; healthcare experience is strongly preferred. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Must possess thorough knowledge of US heathcare system, excellent presentation skills and the ability to assimilate and analyze diverse data to develop tactical action steps to achieve sales results. •  Proficient in Microsoft Office, and strong understanding of pharmaceutical data sets and integration tools. •  Effective people management and performance management skills. •  Exceptional attention to detail and excellent organizational skills. •  Ability to identify the critical issues or opportunities using appropriate information and solve or elevate issues according to reach and severity •  Ability to prioritize responsibilities to meet regular and critical deadlines. •  Ability to contribute to and work within a cross-functional team. •  Excellent verbal and written communication and presentation skills. •  Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. •  Ability to thrive in a dynamic and fast-paced environment. •  Demonstrated ability to develop and monitor procedures and policies. •  Strong math aptitude, analytical skills and the ability to audit detailed reports.