Bristol-Myers Squibb Company

CMC Documentation Manager

Location
New Brunswick, NJ, US
Posted
Jul 21, 2018
Ref
R1508342
Required Education
Doctorate/PHD/MD
Position Type
Full time
Responsibilities:

This position involves coordinating filing activities, compiling information from scientists, and authoring the CMC sections of regulatory documents (e.g., IND, CTA, NDA/BLA) to support the timely submissions of both investigational and marketing applications of small and large molecules. Responsibilities also include coordinating the assembly of prompt and accurate technical responses to inquiries from the FDA and other regulatory agencies on the CMC sections of regulatory documents. Additional responsibilities include designing and writing stability protocols in accordance with established global guidelines, analyzing and trending stability data, and proposing label storage statements and shelf life for drug substance or drug product. These tasks will be performed in close collaboration with the following departments: Chemical & Synthetic Development, Drug Product Science and Technology, Analytical & Bioanalytical Operations, Global Manufacturing and Supply, Drug Safety Evaluation, and Global Regulatory Sciences (GRS-CMC). A successful candidate will also be responsible for providing feedback to the Integrated Development Team on CMC issues and developing timelines for the completion of the CMC sections of regulatory documents. This position deals with complex issues using critical analysis and requires reasoned solutions.

Qualifications

This position involves the critical evaluation of analytical data, knowledge of fundamental principles of organic chemistry and/or pharmaceutical sciences, and experience in drug product and/or drug substance CMC development. A successful candidate is expected to formulate and drive global regulatory writing strategy for CMC submissions, to pay scrupulous attention to detail, to proactively identify key issues, to negotiate the delivery of approved technical documents in accordance with project timelines, and to respond to CMC development opportunities. The candidate should have excellent verbal and written communication skills, as well as scientific judgement and interpersonal skills. This position requires constructive interactions with other members of a team to approach problem-solving. Familiarity with computer-assisted document preparation tools is highly desirable. A Ph.D. or M.S in Pharmaceutics, Organic Chemistry, Biochemistry, or related disciplines with 7-9 years of pharmaceutical development experience is preferred.