Manager, CMC Documentation
Bristol Myers Squibb
June 25, 2026
Remote friendly (New Brunswick, NJ)
United States
Operations
Position Summary:
The Manager, Chemistry, Manufacturing, and Controls (CMC) Documentation & Specifications (New Brunswick, New Jersey) is a technical author of CMC regulatory submissions and specification.
Key Responsibilities:
- Coordinate filing activities and compile information from scientists.
- Author CMC sections of regulatory documents (e.g., IND/CTA, NDA/BLA) to support timely submissions for investigational and marketing applications for small and large molecules.
- Lead specification activities for small molecules.
- Assemble prompt, accurate technical responses to Health Authority inquiries on CMC sections.
- Perform data verification to ensure high-quality regulatory submissions.
- Author approved technical documents per project timelines; proactively identify concerns and provide feedback to the CMC Development Team.
Qualifications & Experience:
- Degree in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences (or related disciplines).
- Preferred: minimum of 5 years pharmaceutical development experience; level may be evaluated based on experience.
Skills/Requirements:
- Excellent verbal and written communication and interpersonal skills.
- Critical analysis and scientific judgment; strong attention to detail.
- Familiarity with computer-assisted document preparation tools (highly desirable).
Compensation/Benefits (as stated):
- Salary range (New Brunswick, NJ): $115,230–$139,637 (full-time).
- Health coverage, wellbeing support, financial wellbeing/protection including 401(k), disability, and life insurance.
Work-life benefits: Paid Time Off (details vary by location/employee type).
The Manager, Chemistry, Manufacturing, and Controls (CMC) Documentation & Specifications (New Brunswick, New Jersey) is a technical author of CMC regulatory submissions and specification.
Key Responsibilities:
- Coordinate filing activities and compile information from scientists.
- Author CMC sections of regulatory documents (e.g., IND/CTA, NDA/BLA) to support timely submissions for investigational and marketing applications for small and large molecules.
- Lead specification activities for small molecules.
- Assemble prompt, accurate technical responses to Health Authority inquiries on CMC sections.
- Perform data verification to ensure high-quality regulatory submissions.
- Author approved technical documents per project timelines; proactively identify concerns and provide feedback to the CMC Development Team.
Qualifications & Experience:
- Degree in organic chemistry, biological sciences, biochemistry, and/or pharmaceutical sciences (or related disciplines).
- Preferred: minimum of 5 years pharmaceutical development experience; level may be evaluated based on experience.
Skills/Requirements:
- Excellent verbal and written communication and interpersonal skills.
- Critical analysis and scientific judgment; strong attention to detail.
- Familiarity with computer-assisted document preparation tools (highly desirable).
Compensation/Benefits (as stated):
- Salary range (New Brunswick, NJ): $115,230–$139,637 (full-time).
- Health coverage, wellbeing support, financial wellbeing/protection including 401(k), disability, and life insurance.
Work-life benefits: Paid Time Off (details vary by location/employee type).