SUMMARY OF POSITION

The Method Development and Analytical Services (MDAS) Scientist is an expert in completing the analytical requirements, testing and other activities to support commercialization of pharmaceutical products. The MDAS Scientist is responsible for all aspects of sample testing, analytical development and validation required to support product development, (A)NDA filing, and commercialization. Responsibilities cover all phases of the project from initial project evaluation through commercialization. The MDAS Scientist provides technical oversight, training, and supervision to personnel performing development, transfer, verification and/or validation of methods related to analyzing raw materials, semi-finished/finished products, and stability. Frequent customer communication, active participation as the analytical chemistry expert on work teams, and problem resolution expertise are required.

ORGANIZATION STRUCTURE

The MDAS Scientist directly reports to a Group Leader, Manager, Director or equivalent level.

RESPONSIBILITIES

• Responsible for technical and scientific integrity of work performed by the MDAS laboratory group within PDTS, ensuring that all work is completed in a scientifically sound, timely and cGMP compliant manner.
• Develop and maintain work plans and schedules to meet the requirements of development projects, process improvement initiatives, or other business needs requiring laboratory support.
• Drive the development and validation strategy for all analytical methods necessary for commercialization of pharmaceutical products. This includes evaluating and defining material specifications, validation/verification/transfer requirements, equipment acquisition/installation, reference standards/reagents, authoring methods/reports, training, safety, and other steps as required.
• Hands-on laboratory bench work and sample testing as required to support development of pharmaceutical products. This includes but not limited to performing assay, related compounds testing, dissolution, uniformity, and other tests to characterize and demonstrate product performance.
• Supervise laboratory bench work to develop, optimize, and troubleshoot analytical methods for testing raw materials and products (semi-finished and finished) supporting technology transfer to the Norwich or other laboratory sites as required.
• Serve as a “Role Model” setting and holding the standard for the group by demonstrating superior leadership, urgency, technical prowess, planning, and communication behaviors in work activities.
• Author and/or approve method validation/verification/transfer protocols and reports compliant with cGMP regulations, industry standards, and customer direction and consistent with the developed installation strategy and project scope.
• Practice effective delegation of responsibility to members of the group including follow up and redirection as required.
• Provide significant scientific contributions toward troubleshooting and improvements. Works through problems with method installation / performance quickly, efficiently, and relentlessly until root cause is determined and solution is found and implemented.
• Provide leadership to project teams as required to set resolve issues, drive decisions, and lead the project forward. Serves as the analytical expert on project teams.
• Work in compliance of all US and international regulatory agencies and compliance requirements as they relate to analytical testing.
• Maintains laboratory equipment and facility. Performs laboratory housekeeping duties as required.
• Travel as required to outside laboratories for the purpose of receiving training from a qualified laboratory or providing training to a receiving laboratory. International travel may be required.

QUALIFICATIONS

• PhD or MS in Chemistry or related science plus 5 years experience in pharmaceutical development. (Equivalent combination of experience and education will be considered – BS degree in Chemistry plus greater than 10 years experience in progressively responsible roles in pharmaceutical development or QC laboratory)
• Expert in GMP regulations and ICH guidelines
• Extensive experience with significant expertise in the majority of the following: HPLC, GC, dissolution, UV-Vis, X-ray diffraction, Karl Fischer, IR, PSD, wet chemistry, and USP/EP compendial test procedures.
• Experience with data acquisition systems such as Empower, ChemStation, etc.
• Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems.
• Advanced computer skills specifically in Microsoft Word, Excel.
• Refined written and verbal communications and presentation skills.
• Strong organizational skills, ability to manage and complete assigned projects on time.
• Experience leading and supervising personnel in a pharmaceutical laboratory setting.

GMP DECISION-MAKING AUTHORITY

The MDAS Scientist has authority to perform and lead work as assigned supporting the laboratory function or supporting development of pharmaceutical products. This includes developing approved procedures and providing guidance to junior staff.

“An Equal Opportunity Employer, including disability/vets.”