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Posted: 10/21/2026Associate Director – Aseptic Facility and Utility Design
Bristol Myers SquibbCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in aseptic processing, contamination control, and microbial risk assessment within regulated pharmaceutical environments, ensuring compliance with industry standards and regulatory guidance. Proven ability to lead cross-functional teams and manage quality oversight for facility and utility design.
Highest-signal resume keywords
Aseptic Processing ExpertiseSterilization ValidationRegulatory Inspection ExperienceContamination Control Strategy DevelopmentLeadership in Quality Assurance
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Review and approve global risk assessments and quality impact assessments for contamination events and microbial control failures involving Facilities & Utilities
- 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 BMS Facilities & Utilities subject matter expert during FDA, EMA, and other health authority inspections
- Provide Global Quality SME review and approval of design packages, URSs, DQ protocols, and change controls for cleanrooms, barrier systems, and critical utilities
- Define and maintain enterprise Quality standards for aseptic facility and utility design
- Provide by-design oversight for facility, utility, and equipment changes to identify and control microbial and particulate contamination risks
- Serve as technical authority for aseptic design during capital projects, facility modifications, and technology transfers
- Integrate contamination control strategy requirements into design specifications
- Provide Quality oversight for WFI, purified water, clean steam, clean compressed gases, and HVAC/clean air systems
- Partner with Engineering and Validation to ensure IQ/OQ/PQ programs demonstrate microbiological and contamination-control performance
- Champion Quality by Design and risk-based thinking across facility and equipment lifecycle management
- Oversee aseptic facility and utility design standards at CMO/CDMO partners
- Support quality risk assessments of external manufacturing facility and utility designs and drive remediation
- Own 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 FDA PAI/GMP, EMA, and PMDA regulatory inspections
- Experience designing or overhauling APS/media fill programs or CCS frameworks at 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 (2022), USP, ISO 13408 series, and PDA Technical Reports TR22, TR13, TR70, and TR90
- Strong command of contamination control strategy (CCS) development
- 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
- Ability to partner cross-functionally across Quality, Operations, MS&T, Regulatory, and Supply Chain
- Up to 25% travel required
- M.S. in a related scientific discipline preferred
Benefits
Comp & perks- Comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance
- 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 non-exempt, RayzeBio, and Puerto Rico employees
- Paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence
- Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
- Additional discretionary incentive cash and stock opportunities
- Reasonable workplace accommodations/adjustments and ongoing support
- Opportunities for growth and a supportive, inclusive, wellbeing-focused work environment
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Microbial Risk AssessmentEnvironmental MonitoringFMEAHACCPFault Tree AnalysisSterilization TechnologiesQuality By DesignDesign Qualification (DQ)Installation Qualification (IQ)Operational Qualification (OQ)
Soft Skills
Cross-Functional CollaborationLeadershipCommunication
Tools & Technologies
Cleanroom ClassificationAirflow Visualization TechniquesSingle-Use SystemsQuality Management Systems
Industry Keywords
FDA Aseptic Processing GuidanceEU GMP Annex 1USPISO 13408PDA Technical ReportsPharmaceutical QualityBiologics ManufacturingContamination Control