Associate Director, Aseptic Facility and Utility Design

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Key Responsibilities Risk Assessment & Quality Impact Governance Review and approve global risk assessments and quality impact assessments (QIAs) associated with contamination events and microbial control failures around Facilities & Utilities. Lead and author high-complexity Business Technical Assessments (BTAs) to support regulatory submissions, systemic issue resolution, and cross-site technical alignment when associated with Facilities & Utilities Develop and maintain comprehensive investigation and inspection-readiness materials for systemic aseptic and microbial control issues, serving as a subject matter expert on BMS Facilities & Utilities during regulatory inspections (FDA, EMA, and other health authorities) Aseptic & Microbial Control by Design Serve as the Global Quality SME for aseptic facility and utility design, providing expert review and approval of design packages, User Requirement Specifications (URS), design qualification (DQ) protocols, and change controls associated with cleanrooms, barrier systems (RABS/isolators), and critical utilities. Define and maintain enterprise-level Quality standards and requirements for aseptic facility and utility design, including cleanroom classification, airflow and pressure differential design, surface finish specifications, and drainability — ensuring alignment with EU GMP Annex 1 (2022), FDA Aseptic Processing Guidance, and ISO 14644 series. Provide by-design oversight for facility, utility and equipment changes — both sterile and non-sterile — ensuring microbial and particulate contamination risks are systematically identified, assessed, and controlled at the design stage 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 critical utility systems — including Water for Injection (WFI), Purified Water (PW), clean steam, clean compressed gases, and HVAC/clean air systems — covering design, qualification, and ongoing microbial and chemical control requirements. Partner with Engineering and Validation teams to ensure facility and utility qualification (IQ/OQ/PQ) programs adequately demonstrate microbiological and contamination control performance against defined acceptance criteria. Champion Quality by Design (QbD) and risk-based thinking across all phases of facility and equipment lifecycle management Provide oversight of aseptic facility and utility design standards at ExM partners (CMOs/CDMOs), reviewing facility design packages, CCS documentation, and utility qualification strategies as part of site qualification and ongoing oversight programs, as required. Support quality risk assessments of ExM facility and utility design, identifying gaps relative to BMS standards and current regulatory expectations, and driving remediation through the ExM quality governance framework Sterilization Standards & Single-Use Technology (SUT) Own the development and governance of enterprise design standards for sterilization technologies, with expertise in 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 both MS&T and Engineering in design decisions Ensure sterilization design standards remain current with evolving regulatory guidance (e.g., ISO 11135, ISO 11137, ISO 11040) and industry best practices Qualifications & Experience Education Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline. Experience 10+ years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality — with 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. Demonstrated experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA). Proven track record in 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. Skills & Competencies Expert-level knowledge of aseptic processing regulations and guidance: FDA Aseptic Processing Guidance (2004/Revised), EU GMP Annex 1 (2022), USP , ISO 13408 series, PDA Technical Reports (TR22, TR13, TR70, TR90). Strong command of contamination control strategy (CCS) development as required under EU GMP Annex 1. Proficiency in risk assessment methodologies: FMEA, HACCP, fault tree analysis, risk ranking and filtering. Familiarity with facility design standards, cleanroom classification, and airflow visualization techniques. Experience with sterilization technologies: EtO, gamma, steam (moist heat), dry heat, and VHP/HPV. Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain. Travel: This position requires up to 25% of travel. Preferred: M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. Compensation Overview: Devens - MA - US: $173,280 - $209,976 Madison - Giralda - NJ - US: $161,950 - $196,246 New Brunswick - NJ - US: $161,950 - $196,246 Princeton - NJ - US: $161,950 - $196,246 Seattle - WA: $178,140 - $215,867 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance. Benefits: Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including 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. Eligi