Associate Director, Aseptic Operational Support

Bristol Myers Squibb • Devens, MA

2d • $161,950 - $209,976

About The Position

The Associate Director provides authoritative technical input 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 serves as the MQSA voice to ensure sterility assurance and microbial control requirements are incorporated into facilities. The role provides technical oversight and strategic direction across facility, utility, equipment, and process domains at RayzeBio and BMS internal manufacturing sites, as well as oversight of external manufacturing partners.

The position governs quality risk assessments and quality impact assessments related to contamination events and microbial control failures; leads complex Business Technical Assessments; and supports regulatory submissions, systemic issue resolution, and inspection readiness. As the global Quality subject matter expert for aseptic facility and utility design, it reviews design documentation and establishes enterprise standards aligned with applicable regulatory requirements. It provides Quality oversight across facility and utility design, qualification, and lifecycle changes, including critical utilities, sterilization technologies, and single-use systems.

The role requires a B.S. in a relevant scientific discipline and at least 10 years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality, including at least 4 years in a leadership or enterprise-level role. The position requires up to 25% travel. A relevant M.S. is preferred.

Requirements

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• At least 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 in a regulated pharmaceutical or biologics manufacturing environment.
• Demonstrated experience authoring and defending technical positions during regulatory inspections, including FDA PAI/GMP, EMA, and PMDA inspections.
• Proven 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 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 complex Business Technical Assessments (BTAs) 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 FDA, EMA, and other health authority inspections.
• Serve as the Global Quality SME for aseptic facility and utility design, reviewing and approving design packages, User Requirement Specifications (URS), design qualification (DQ) protocols, and change controls for cleanrooms, RABS, isolators, 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, aligned with applicable regulatory standards.
• Provide design-stage oversight of facility, utility, and equipment changes, identifying, assessing, and controlling microbial and particulate contamination risks for sterile and non-sterile changes.
• Serve as the technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers, integrating contamination control strategy (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 (QbD) and risk-based thinking throughout facility and equipment lifecycle management.
• Oversee aseptic facility and utility design standards at external manufacturing partners, reviewing design packages, CCS documentation, and utility qualification strategies as part of site qualification and ongoing oversight.
• Support quality risk assessments of external manufacturing facility and utility designs, identify gaps against BMS standards and regulatory expectations, and drive remediation through the external manufacturing quality governance framework.
• Own the development and governance of enterprise design standards for sterilization technologies, including single-use technology (SUT) 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.
• Ensure sterilization design standards remain current with regulatory guidance and industry best practices.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 160 hours of paid vacation annually for new hires, subject to manager approval, for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays each year.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 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.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

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