CMC Manager

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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 leading specification activities for small molecules and coordinating the assembly of prompt and accurate technical responses to inquiries from global Health Authorities on the CMC sections of regulatory documents.

These tasks will be performed in close collaboration with the following departments: Chemical Process Development, Drug Product Development, Analytical Strategy & Operations, Product Development Operations, Portfolio Strategy and Integration, Manufacturing Science and Technology, Clinical Supply Operations, Drug Safety Evaluation, and Global Regulatory Sciences (GRS-CMC). A successful candidate will also be responsible for providing feedback to the CMC 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 Organic Chemistry or related disciplines with 7–10 years of pharmaceutical development experience is preferred.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com