Associate Director, Aseptic Operational Support

Bristol Myers Squibb

. Provide authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments .

Posted 10/25/2026full-timeUnited StatesSenior💰 $161,950 - $209,976 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in aseptic processing, sterility assurance, and microbial risk assessment within regulated pharmaceutical environments, with a strong focus on contamination control strategies and regulatory compliance.

Highest-signal resume keywords

Aseptic Processing ExpertiseSterilization ValidationRegulatory Inspection ExperienceContamination Control Strategy DevelopmentLeadership in Quality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

MicrobiologyPharmaceutical QualityEnvironmental MonitoringRisk AssessmentFMEAHACCPFault Tree AnalysisSterilization TechnologiesAseptic ManufacturingQuality Impact Assessment

Tools & Technologies

Cleanroom ClassificationAirflow Visualization TechniquesSingle-Use System QualificationAPS/Media Fill ProgramsCCS Frameworks

Industry Keywords

FDA Aseptic Processing GuidanceEU GMP Annex 1USPISO 13408PDA Technical ReportsMicrobial ControlQuality By DesignRegulatory SubmissionsContamination EventsSystemic Issue Resolution

Tech Stack

Tools & technologies

Airflow

About the role

Key responsibilities & impact

Provide authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments
Partner with MS&T on technology transfer and process design activities
Partner with Engineering on capital project execution
Serve as the MQSA voice ensuring sterility assurance and microbial control requirements are built into facilities
Review and approve global risk assessments and quality impact assessments related to contamination events and microbial control failures
Lead and author high-complexity Business Technical Assessments for regulatory submissions, systemic issue resolution, and cross-site technical alignment
Develop and maintain investigation and inspection-readiness materials for systemic aseptic and microbial control issues
Serve as a subject matter expert during regulatory inspections
Serve as Global Quality SME for aseptic facility and utility design
Review and approve design packages, URS, DQ protocols, and change controls for cleanrooms, barrier systems, and critical utilities
Define and maintain enterprise-level quality standards for aseptic facility and utility design
Provide by-design oversight for facility, utility, and equipment changes
Serve as technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers
Integrate contamination control strategy requirements into design specifications
Provide Quality oversight for WFI, PW, clean steam, clean compressed gases, and HVAC/clean air systems
Partner with Engineering and Validation teams on IQ/OQ/PQ qualification programs
Champion Quality by Design and risk-based thinking across facility and equipment lifecycles
Oversee aseptic facility and utility design standards at ExM partners, including CMOs/CDMOs
Support quality risk assessments of ExM facility and utility design and drive remediation
Own development and governance of enterprise design standards for sterilization technologies, single-use technology, and consumable qualification
Define sterilization validation requirements and risk-based bioburden control strategies
Ensure sterilization design standards remain current with regulatory guidance and industry best practices

Requirements

What you’ll need

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
10+ years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality
At least 4 years in a leadership or enterprise-level role
Deep technical expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment within a regulated pharmaceutical or biologics manufacturing environment
Experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA)
Experience designing or overhauling APS/media fill programs or CCS frameworks at a network or enterprise scale
Hands-on experience with sterilization validation and single-use system qualification
Expert-level knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1, USP, ISO 13408 series, and PDA Technical Reports (TR22, TR13, TR70, TR90)
Strong command of contamination control strategy (CCS) development under EU GMP Annex 1
Proficiency in FMEA, HACCP, fault tree analysis, and risk ranking and filtering
Familiarity with facility design standards, cleanroom classification, and airflow visualization techniques
Experience with EtO, gamma, steam (moist heat), dry heat, and VHP/HPV sterilization technologies
Up to 25% travel required

Benefits

Comp & perks

Comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and 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 in Puerto Rico: 160 hours of paid vacation annually for new hires
Non-exempt employees, RayzeBio employees, and employees in Puerto Rico: 3 optional holidays
Paid sick leave, depending on eligibility
Up to two paid volunteer days per year, depending on eligibility
Summer hours flexibility, depending on eligibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
Additional discretionary incentive cash and stock opportunities may be available