Senior Manager, Contamination Events and Investigations

Bristol Myers Squibb

. Support complex microbiological and sterility assurance investigations at BMS internal manufacturing sites, including environmental monitoring excursions, sterility test failures, and process-related contamination events .

Posted 9/17/2026full-timeNew Brunswick • New Jersey • United StatesSenior💰 $116,440 - $155,211 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in microbiology and sterility assurance, with a strong focus on aseptic processing, contamination control, and regulatory compliance. Proven ability to lead complex investigations, develop CAPA strategies, and collaborate effectively across functions in a GMP-regulated environment.

Highest-signal resume keywords

Microbiology ExpertiseAseptic Processing OperationsRegulatory Compliance (FDA 21 CFR, EU GMP Annex 1)Root Cause Analysis (RCA) MethodsTechnical Writing for Regulatory Reports

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

MicrobiologySterility AssuranceAseptic ManufacturingEnvironmental MonitoringCAPA DevelopmentRegulatory WritingContamination Control StrategyIsolator TechnologyPerformance DashboardsTrend Analytics

Soft Skills

CollaborationExecutive CommunicationInfluencing Without AuthorityCross-Functional Partnership

Tools & Technologies

Performance DashboardsTrend Analytics Tools

Industry Keywords

GMP-Regulated EnvironmentBiologicsCell TherapyGene TherapyEnvironmental Monitoring ProgramsContamination ControlMicrobial SamplingRegulatory Agency InspectionsQuality Risk AssessmentsGlobal Health Authorities

About the role

Key responsibilities & impact

Support complex microbiological and sterility assurance investigations at BMS internal manufacturing sites, including environmental monitoring excursions, sterility test failures, and process-related contamination events
Serve as the MQSA SME for microbiological and aseptic process impact assessments
Evaluate root cause analyses and assess product, process, and patient impact
Review and formally sign off on impact assessments, investigation reports, CAPA records, and deviation documentation
Partner with site Investigation Leads to ensure investigation scope, RCA depth, and CAPA effectiveness address microbiological and aseptic process risk
Lead rapid containment and triage for sterility breaches, leaks, mold recoveries, and contamination events
Track and trend impact assessment outcomes to identify systemic issues and emerging risks
Support regulatory agency inspections and audits related to impact assessment findings and sterility assurance
Serve as technical liaison for External Manufacturing partners on sterility and microbiological investigations
Review ExM impact assessments and investigation reports and provide feedback on risk evaluation and CAPA responses
Support CMO quality risk assessments and periodic reviews of aseptic processing, contamination control, and microbiological data trends
Design and implement standardized CMO oversight tools, dashboards, and decision trees
Participate in remote and on-site technical reviews with CMOs during escalated events or regulatory commitments
Participate in CMO site assessments and vendor selection; serve as technical SME on External Manufacturing quality audit teams
Provide expertise on barrier technology, cleanroom design, gowning programs, and aseptic technique qualification
Support aseptic process simulations/media fills, process validation, and revalidation activities
Contribute to contamination control strategies aligned with EU GMP Annex 1 (2022)
Review aseptic process change controls and provide risk-based SME input
Support cGMP improvements and regulatory guidance interpretation
Consult on microbial sampling during technology transfers and qualification activities
Author and approve CMC documents for process validation P.3.5 sections
Support CMC queries and resolutions with Global Health Authorities and support plant inspections
Mentor site-level microbiologists and quality professionals
Contribute to global MQSA standards, SOPs, guidance documents, and training materials
Monitor industry trends, regulatory updates, and scientific literature
Represent MQSA in cross-functional teams, steering committees, and governance forums
Interface with BPOG, ISPE, and PDA industry consortiums

Requirements

What you’ll need

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
Minimum 8 years of direct experience in microbiology, sterility assurance, or aseptic manufacturing within a GMP-regulated pharmaceutical or biopharmaceutical environment
Deep expertise in aseptic processing operations, environmental monitoring programs, and sterility test methodologies
Experience in biologics and/or cell therapy, or gene therapy
Experience leading complex microbiological investigations, RCA methods, and CAPA development
Strong technical writing skills and experience authoring regulatory-grade investigation reports and deviation records
Working knowledge of FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, ICH Q9/Q10, and USP chapters
Ability to collaborate across functions and geographies in a matrix organization without direct authority
Experience supporting or overseeing External Manufacturing partners from a microbiology and sterility assurance perspective
Familiarity with contamination control strategy (CCS) development aligned with EU GMP Annex 1 (2022 revision)
Experience with isolator and/or RABS barrier technology in aseptic manufacturing
Participation in FDA, MHRA, or EMA regulatory agency inspections as a SME or technical reviewer
Ability to translate site-level data into network-wide strategy and risk management decisions
Recognized expertise in aseptic sciences, contamination control, and environmental monitoring
Executive communication skills for senior leadership, regulatory agencies, and external partners
Ability to influence without direct authority across a complex, matrixed global organization
Proficiency in performance dashboards, trend analytics, and KPIs
Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain
Up to 25% travel required

Benefits

Comp & perks

Additional discretionary incentive cash and stock opportunities
Wellbeing support
Retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
U.S.-based exempt employees: Flexible Time Off (FTO) without a set accrual limit, subject to manager approval
11 paid company holidays each year
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires
3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
Paid sick leave, depending on eligibility
Up to two paid volunteer days per year
Summer hours flexibility
Medical, personal, parental, caregiver, bereavement, or military leaves of absence
Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
Workplace accommodations/adjustments and ongoing support for people with disabilities