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Bristol Myers Squibb

Senior Manager of CMC - Quality Assurance

Bristol Myers Squibb

Indianapolis, IN · full time · Senior

$141,515 – $171,483

Listed on Bristol Myers Squibb’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This role oversees quality assurance strategies for radiopharmaceutical manufacturing and analytics across the development lifecycle, from preclinical through post-approval. It suits experienced quality professionals in biologics or sterile drug manufacturing who want to drive CMC strategy and regulatory submissions at a biotech focused on oncology.

Our summary, not Bristol Myers Squibb’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • Bachelor's degree in Chemistry, Biochemistry, or similar scientific field
  • Five or more years of hands-on experience in biologics or sterile manufacturing/analytical work in development or operations
  • Knowledge of bulk biologic drug substance and radiopharmaceutical development/manufacturing
  • Thorough understanding of cGMPs and FDA/EU/ICH regulatory requirements
  • Experience bringing multiple INDs through to BLA/NDA approval
  • Ability to work in GMP cleanroom environment and handle radioactive materials
  • Located at or willing to relocate to Indianapolis manufacturing facility

Nice to have

  • Prior experience in Quality functions
  • Experience with monoclonal antibody, bispecific, cell/gene therapy, or radiopharmaceutical manufacturing
  • Demonstrated strategic thinking and negotiation skills
  • Experience introducing best practices into quality management systems

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