FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior Manager, Internal Contamination Events & Investigations
Bristol Myers Squibb. Support complex microbiological and sterility assurance investigations at internal manufacturing sites, including environmental monitoring excursions, sterility test failures, and process-related contamination events .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in microbiology and sterility assurance, with a strong focus on aseptic processing, environmental monitoring, and regulatory compliance. Proven ability to lead complex investigations, develop CAPA strategies, and support external manufacturing quality assessments.
Highest-signal resume keywords
Aseptic Processing OperationsMicrobiological InvestigationsRegulatory Compliance (FDA 21 CFR, EU GMP)Technical Writing for Regulatory ReportsContamination Control Strategy Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
MicrobiologySterility AssuranceAseptic ManufacturingRoot Cause Analysis (RCA)CAPA DevelopmentEnvironmental MonitoringRegulatory Guidance InterpretationProcess ValidationGMP RegulationsBarrier Technology (Isolator/RABS)
Soft Skills
CollaborationMentoringCommunicationProblem-SolvingLeadership
Tools & Technologies
CMO Oversight ToolsDashboardsDecision TreesCleanroom DesignGowning Programs
Industry Keywords
BiologicsCell TherapyGene TherapyCGMPFDA InspectionsMHRA InspectionsEMA InspectionsMicrobial SamplingSOP DevelopmentQuality Risk Assessment
About the role
Key responsibilities & impact- Support complex microbiological and sterility assurance investigations at internal manufacturing sites, including environmental monitoring excursions, sterility test failures, and process-related contamination events
- Serve as 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 investigation reports, CAPA records, and deviation documentation
- Partner with site Investigation Leads on investigation scope, RCA depth, and CAPA effectiveness
- 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 assessments and sterility assurance
- Act as technical liaison for External Manufacturing partners on sterility and microbiological investigations
- Review ExM investigation reports and impact assessments and provide feedback
- Support CMO quality risk assessments and periodic reviews of aseptic operations, contamination control programs, and microbiological trends
- Design and implement CMO oversight tools, dashboards, and decision trees
- Participate in remote and on-site CMO technical reviews, site assessments, vendor selection, and external manufacturing audits
- Provide expertise in aseptic processing, barrier technology, cleanroom design, gowning programs, and aseptic technique qualification
- Support media fills, process validation, revalidation, contamination control strategies, and aseptic process change controls
- Support cGMP improvements and regulatory guidance interpretation
- Consult on microbial sampling during technology transfers and qualification activities
- Author and approve CMC process validation P.3.5 documentation
- Support CMC queries with Global Health Authorities and plant inspections
- Mentor site-level microbiologists and quality professionals
- Develop and maintain 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, PDA, and similar 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
- Demonstrated experience leading complex microbiological investigations, RCA methods, and CAPA development
- Strong technical writing skills with 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 work effectively in a matrix organization across functions and geographies 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 inspections as a SME or technical reviewer
- Up to 25% travel required
- Preferred: M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
Benefits
Comp & perks- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) for U.S.-based exempt employees
- 11 paid company holidays each year
- 160 hours of paid vacation annually for eligible new hires
- 3 optional holidays for eligible employees
- Paid sick leave
- 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
- Additional discretionary incentive cash and stock opportunities
- Flexible work models, including site-essential, site-by-design, field-based and remote-by-design