Senior Manager of CMC - Quality Assurance
Bristol Myers Squibb
June 24, 2026
On-site
Indianapolis, IN
Operations
Senior Manager, Chemistry, Manufacturing & Controls (CMC) – Quality Assurance
Job Responsibilities
- Provide Quality (QA) input to CMC Development Teams from pre-clinical through end of product life cycle, including NDA filing, other market filings, and post-approval changes; partner with SMEs to develop/approve CMC strategy (DS, DP, analytical) for new candidates.
- Manage compound/product-specific change control across the product lifecycle, including impact assessments, tracking, and implementation; oversee and approve key Quality System deliverables (deviations, investigations, CAPAs, complaints) as appropriate.
- Review and approve analytical method lifecycle documents (API/bulk drug product specifications, analytical test methods incl. micro, protocols/reports) including stability.
- Conduct compound/product-specific risk assessments for all aspects of drug development; communicate Quality risks within the Quality organization.
- Collaborate with Regulatory to own/track Quality input for ongoing regulatory filings and Health Authority updates (e.g., IND/IMPD/BLA/NDA), including specifications and shelf-life extensions.
Education/Experience
- B.S. degree (preferably Chemistry, Biochemistry, or similar).
- 5+ years hands-on biologics/sterile experience in development/operations (manufacturing and/or analytical).
- Prior Quality experience (preferred).
Skills/Qualifications
- Thorough knowledge of pharmaceutical development processes (e.g., bringing multiple INDs to successful BLA/NDA approval); knowledge of bulk biologic drug substance, parenteral drug product, cell/gene therapy and/or radiopharmaceutical development/manufacturing.
- CMC expert; can introduce best practices into quality management systems.
- Strong cGMP and regulatory knowledge (FDA, EU, ICH).
- Strong QA/investigational problem-solving and analytical mindset; can define/implement QA action plans.
- Independent and collaborative; attention to detail; manage multiple tasks in a fast-paced environment.
- Ability to work across functional groups; applies AI to improve execution/decision-making; continuous improvement mindset.
Work/Physical Requirements
- GMP cleanroom environment; protective clothing and handling radioactive materials.
- Regularly sit/reach/talk or hear; occasionally lift/move up to 30 lbs; close and distance vision required.
- Travel up to 20% (outside Indianapolis).
Location: Indianapolis manufacturing facility (must be located at site).
Job Responsibilities
- Provide Quality (QA) input to CMC Development Teams from pre-clinical through end of product life cycle, including NDA filing, other market filings, and post-approval changes; partner with SMEs to develop/approve CMC strategy (DS, DP, analytical) for new candidates.
- Manage compound/product-specific change control across the product lifecycle, including impact assessments, tracking, and implementation; oversee and approve key Quality System deliverables (deviations, investigations, CAPAs, complaints) as appropriate.
- Review and approve analytical method lifecycle documents (API/bulk drug product specifications, analytical test methods incl. micro, protocols/reports) including stability.
- Conduct compound/product-specific risk assessments for all aspects of drug development; communicate Quality risks within the Quality organization.
- Collaborate with Regulatory to own/track Quality input for ongoing regulatory filings and Health Authority updates (e.g., IND/IMPD/BLA/NDA), including specifications and shelf-life extensions.
Education/Experience
- B.S. degree (preferably Chemistry, Biochemistry, or similar).
- 5+ years hands-on biologics/sterile experience in development/operations (manufacturing and/or analytical).
- Prior Quality experience (preferred).
Skills/Qualifications
- Thorough knowledge of pharmaceutical development processes (e.g., bringing multiple INDs to successful BLA/NDA approval); knowledge of bulk biologic drug substance, parenteral drug product, cell/gene therapy and/or radiopharmaceutical development/manufacturing.
- CMC expert; can introduce best practices into quality management systems.
- Strong cGMP and regulatory knowledge (FDA, EU, ICH).
- Strong QA/investigational problem-solving and analytical mindset; can define/implement QA action plans.
- Independent and collaborative; attention to detail; manage multiple tasks in a fast-paced environment.
- Ability to work across functional groups; applies AI to improve execution/decision-making; continuous improvement mindset.
Work/Physical Requirements
- GMP cleanroom environment; protective clothing and handling radioactive materials.
- Regularly sit/reach/talk or hear; occasionally lift/move up to 30 lbs; close and distance vision required.
- Travel up to 20% (outside Indianapolis).
Location: Indianapolis manufacturing facility (must be located at site).