Sr. Manager, Contamination Events and Investigations

Bristol Myers Squibb · New Brunswick, NJ +5 more

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QualityFull-time$116k–$141kCompany career page

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Role summary

Senior Manager responsible for leading contamination investigations and microbiological assessments across Bristol Myers Squibb's internal and contract manufacturing sites. Provides expertise in sterility assurance, aseptic processing, and regulatory compliance while mentoring site-level quality professionals and developing global standards.

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 environment
Deep expertise in aseptic processing, environmental monitoring programs, and sterility test methodologies
Experience with biologics, cell therapy, or gene therapy manufacturing
Demonstrated ability to lead complex microbiological investigations and root cause analyses
Knowledge of FDA, EMA, and ICH regulatory expectations for sterility and contamination control

What you'll be doing

Lead microbiological investigations and impact assessments for contamination events at internal manufacturing sites
Review and approve investigation reports, CAPA documentation, and deviation records for scientific soundness and regulatory alignment
Manage rapid response and triage for sterility breaches and contamination events across multiple sites
Provide technical oversight and SME guidance to external manufacturing partners on investigation quality and standards
Design and implement CMO oversight tools, dashboards, and contamination control strategies per current regulatory guidance

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