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Bristol Myers Squibb logo

Senior Manager, Internal Contamination Events & Investigations

Bristol Myers Squibb · New Brunswick, NJ +5 more

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SafetyFull-time$144k–$175kCompany career page

The apply link worked recently (not employer-confirmed).

Role summary

Senior Manager responsible for leading microbiological investigations and sterility assurance across Bristol Myers Squibb's internal and contract manufacturing sites. Position involves impact assessment of contamination events, oversight of external manufacturing partners, and technical leadership in aseptic processing compliance.

What they're looking for

  • Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related discipline
  • Minimum 8 years direct experience in microbiology or sterility assurance in GMP-regulated pharmaceutical/biopharmaceutical environment
  • Deep expertise in aseptic processing operations, environmental monitoring, and sterility test methodologies
  • Knowledge of FDA, EMA, and ICH regulatory expectations for contamination investigations
  • Subject matter expert capability in microbiological impact assessment and root cause analysis
  • Experience with contract manufacturer oversight and vendor technical audits
  • Familiarity with current industry standards, RABS/isolator technology, and cleanroom operations

What you'll be doing

  • Lead microbiological investigations for environmental monitoring excursions, sterility failures, and contamination events at internal manufacturing sites
  • Provide expert sign-off on impact assessments, CAPA records, and regulatory documentation ensuring scientific soundness and compliance alignment
  • Serve as technical liaison to external manufacturing partners, reviewing investigations and driving quality standards at contract manufacturing organizations
  • Support aseptic process simulations, validation activities, and contamination control strategy development aligned with Annex 1 requirements
  • Mentor site-level microbiologists and quality professionals; contribute to development of global standards, SOPs, and training materials

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