Manager, CMC Documentation
About The Position
The Manager, Chemistry, Manufacturing, and Controls (CMC) Documentation & Specifications will join our team located in New Brunswick, New Jersey as a technical author of CMC regulatory submissions and specification. The successful candidate excels in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences and has experience in pharma and/or biologics CMC drug substance and/or drug product development. This role will be performed in close collaboration with other groups within Analytical Strategy & Operations as well as the following departments: Chemical Process Development, Biologics Development, Drug Product Development, Portfolio Strategy & Integration, Manufacturing Science & Technology, Clinical Supply Operations, Nonclinical Safety, and Global Regulatory Sciences.
Requirements
- A degree in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences, or related disciplines with a minimum of 5 years of pharmaceutical development experience is preferred.
- Excellent verbal and written communication skills and interpersonal skills.
- Constructive interactions with other members of a team to approach problem solving.
- Familiarity with computer-assisted document preparation tools is highly desirable.
Responsibilities
- 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 for small and large molecules.
- 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.
- Data verification to ensure high quality regulatory submissions.
- Authoring the approved technical documents in accordance with project timelines.
- Proactively identify concerns and provide feedback to the CMC Development Team on potential issues.
- Use critical analysis and scientific judgment to solve problems.
- Pay scrupulous attention to detail.
Benefits
- Medical, pharmacy, dental, and vision care.
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires with manager approval
- 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
