Manager, CMC Documentation

Position Summary 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 specifications. Key Responsibilities Coordinate filing activities and compile information from scientists. Author the CMC sections of regulatory documents (e.g., IND/CTA, NDA/BLA) to support timely submissions of investigational and marketing applications for small and large molecules. Lead specification activities for small molecules. Coordinate assembly of accurate technical responses to inquiries from global Health Authorities on CMC sections. Verify data to ensure high‑quality regulatory submissions. Author approved technical documents within project timelines and provide proactive feedback to the CMC Development Team on potential issues. Apply critical analysis and scientific judgment to solve problems with careful attention to detail. Qualifications & Experience Degree in organic chemistry, biological sciences, biochemistry, pharmaceutical sciences, or related disciplines. Minimum 5 years of pharmaceutical development experience (pharma and/or biologics CMC drug substance and/or drug product development). Excellent verbal and written communication skills and strong interpersonal skills. Constructive interaction with team members for problem solving. Familiarity with computer‑assisted document preparation tools is highly desirable. Compensation Overview New Brunswick - NJ - US: $115,230 - $139,637 The starting compensation range is for a full‑time employee. Additional incentive cash and stock opportunities may be available. Benefits Health Coverage: Medical, pharmacy, dental, and vision. Wellbeing Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs. Financial Well‑being: 401(k), disability, life insurance, supplemental health insurance, travel protection. Work‑life benefits: Paid Time Off, flexible time off, paid vacation, national holidays, volunteer days, summer hours flexibility. Location & On‑Site Requirements Roles are located in New Brunswick, New Jersey. The occupancy type for this role is site‑essential, requiring 100% of shifts onsite at the facility. Equal Employment Opportunity BMS is a committed equal opportunity employer inclusive of diverse backgrounds and supports people with disabilities. Qualified applicants with arrest and conviction records will be considered, in compliance with applicable laws. #J-18808-Ljbffr Dormont Manufacturing Co