Associate Director, Aseptic Operational Support

Bristol Myers Squibb • Princeton, NJ

12h

About The Position

The Associate Director provides authoritative technical input and strategic direction on facility and utility design standards, risk assessments, and quality impact assessments. The role partners closely with MS&T on technology transfer and process design, and with Engineering on capital project execution. It does not own facility construction or engineering delivery; instead, it represents MQSA to ensure sterility assurance and microbial control requirements are incorporated into facility design. The position provides technical oversight across facility, utility, equipment, and process domains at RayzeBio and BMS internal manufacturing sites, as well as external manufacturing partners as required.

The role governs risk assessments and quality impact assessments related to contamination events and microbial control failures, authors high-complexity Business Technical Assessments, and develops inspection-readiness materials for systemic aseptic and microbial control issues. It serves as a subject matter expert on BMS Facilities & Utilities during regulatory inspections.

As the Global Quality SME for aseptic facility and utility design, the Associate Director reviews and approves design packages, URSs, DQ protocols, and change controls. The role establishes enterprise quality standards for aseptic facilities and utilities, provides by-design oversight for facility, utility, and equipment changes, and integrates contamination control strategy requirements into design specifications. It also provides quality oversight for critical utilities and partners with Engineering and Validation to ensure qualification programs demonstrate microbiological and contamination control performance.

The position champions Quality by Design and risk-based lifecycle management, oversees design standards at external manufacturing partners, and owns enterprise design standards for sterilization technologies. It defines sterilization validation requirements and risk-based bioburden control strategies for components, containers, and sterile fluid pathways, keeping standards aligned with evolving regulations and industry practices. Travel of up to 25% is required.

Requirements

• 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 of experience in a leadership or enterprise-level role.
• Deep technical expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment in regulated pharmaceutical or biologics manufacturing.
• Demonstrated experience authoring and defending technical positions during regulatory inspections, including FDA PAI/GMP, EMA, and PMDA inspections.
• Proven track record 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 aseptic processing regulations and guidance, including FDA Aseptic Processing Guidance, EU GMP Annex 1, USP <1116>, ISO 13408 series, and PDA Technical Reports TR22, TR13, TR70, and TR90.
• Strong command of contamination control strategy development as required under EU GMP Annex 1.
• Proficiency in risk assessment methodologies, including 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.
• Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain.
• Ability to travel up to 25%.

Nice To Haves

• M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

Responsibilities

• Review and approve global risk assessments and quality impact assessments associated with 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 related to Facilities & Utilities.
• Develop and maintain investigation and inspection-readiness materials for systemic aseptic and microbial control issues, and serve as a Facilities & Utilities subject matter expert during regulatory inspections.
• Serve as Global Quality SME for aseptic facility and utility design, reviewing and approving 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, including cleanroom classification, airflow and pressure differentials, surface finishes, and drainability.
• Provide by-design oversight for sterile and non-sterile facility, utility, and equipment changes, ensuring microbial and particulate contamination risks are identified, assessed, and controlled.
• Serve as technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers, integrating CCS requirements into design specifications.
• Provide Quality oversight for WFI, purified water, clean steam, clean compressed gases, and HVAC/clean air systems, including design, qualification, and ongoing microbial and chemical control requirements.
• Partner with Engineering and Validation to ensure IQ/OQ/PQ programs demonstrate microbiological and contamination control performance against defined acceptance criteria.
• Champion Quality by Design and risk-based thinking across facility and equipment lifecycle management.
• Oversee aseptic facility and utility design standards at external manufacturing partners, reviewing facility design packages, CCS documentation, and utility qualification strategies as required.
• Support quality risk assessments of external manufacturing facility and utility designs, identify gaps against BMS standards and regulatory expectations, and drive remediation through ExM quality governance.
• Own the development and governance of enterprise design standards for sterilization technologies, with expertise in single-use technology and consumable qualification.
• Define sterilization validation requirements and risk-based bioburden control strategies for components, containers, and sterile fluid pathways, supporting MS&T and Engineering design decisions.
• Keep sterilization design standards current with evolving regulatory guidance and industry best practices.
• Travel up to 25%.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and insurance offerings such as medical, dental, vision, life, and disability.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt, RayzeBio, and Puerto Rico employees.
• 11 paid company holidays each year; eligible employees in certain groups also receive 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director