Associate Director, Aseptic Operational Support

Bristol Myers Squibb • Indianapolis, IN

9d

About The Position

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

This role leads quality governance for facility and utility risk assessments and quality impact assessments, contributes to regulatory submissions and systemic issue resolution, and serves as a subject matter expert during regulatory inspections. It establishes and maintains enterprise standards for aseptic facility and utility design, including cleanroom and critical utility requirements, and provides quality oversight throughout design, qualification, change management, capital projects, and technology transfers. The position also governs sterilization design standards and single-use technology qualification, and supports sterilization validation and bioburden control strategies.

The position is a two-year term based in Indianapolis; after the two years, the position will be based in New Jersey or Massachusetts. Travel of up to 25% is required.

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 of experience 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 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 (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; 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, 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, aligned with applicable regulatory and industry standards.
• Provide by-design oversight for facility, utility, and equipment changes, ensuring microbial and particulate contamination risks are 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, incorporating 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 controls.
• 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 across 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 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 MS&T and Engineering design decisions.
• Keep sterilization design standards current with regulatory guidance and industry best practices.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life, and disability).
• Flexible Time Off (FTO) for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays each year; eligible employees in specified categories 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 discretionary incentive cash and stock opportunities.

What This Job Offers

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