Key Responsibilities
Enterprise Governance & Leadership
Govern enterprise aseptic and microbial control practices, including the design and management of escalation pathways, cross-functional forums, and structured decision frameworks
Provide executive-level leadership for Quality Council and EAC activities related to sterility assurance and contamination control
Define and maintain clear thresholds for escalation of contamination events, systemic risks, and critical microbial control deviations across sterile and non-sterile manufacturing sites
Establish and own enterprise-wide policies, standards, and procedures governing aseptic operations, environmental monitoring, and microbial control programs
Strategy, Roadmap & Performance Monitoring
Define the enterprise aseptic, microbial control, and sterility assurance roadmap — inclusive of short-term priorities and long-range capability-building strategies
Establish enterprise KPIs and a comprehensive performance monitoring strategy to measure program effectiveness, site compliance, and continuous improvement outcomes
Lead enterprise trend detection, signal monitoring, and recurring event analysis across both sterile and non-sterile manufacturing environments
Cross-Site Harmonization & Knowledge Management
Build,facilitate, and sustain a Community of Practice (CoP) for sterility assurance and contamination control, enabling knowledge sharing, peer learning, and best practice dissemination
Technical Authority & Contamination Event Leadership
Serve as the enterprise technical authority for all matters related to sterility assurance, contamination control, aseptic processing, and microbial risk management
Lead governance andoversight of high-risk, systemic, or cross-site contamination events including Subject Matter Expert (SME) impact assessments, root cause investigations, and CAPAs
Environmental Monitoring Program Ownership
Lead periodic review and modernization of EM standards in alignment with evolving regulatory expectations and industry best practices (e.g., PDA, USP, EU GMP Annex 1)
CMO Oversight
SelectionProcess, Qualification & Ongoing Governance
Provides technical input for CMO escalations, deviations, investigations, and technology transfers involving aseptic or microbial control considerations
Gowning, Personnel Flow & Aseptic Facility Design Guidance
Support facility design reviews and cleanroom classification initiatives, providing expert input on layout, pressure differentials, and contamination control by design
Qualifications & Experience
Education
Required:Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
Experience
15+ yearsof progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
Deep experienceworking in manufacturing facilitiesacross multiple manufacturing modalities, includingsmall molecule, biologics, cell therapy, or gene therapy
Demonstratedexpertiseinglobal regulatory frameworks(FDA 21 CFR Parts 210/211/600, EU GMP Annex 1,Part IV for Advanced Therapies,ICH Q9/Q10, USP <797>/<1072>/<71>, PIC/S, and other applicable guidance)
Proven experience leading or supportingregulatory inspections(FDA PAI/GMP, EMA, MHRA, or equivalent)
Skills & Competencies
Collaboration:Strong cross-functional partnership skills across Quality, Operations,MS&T,Regulatory, and Supply Chain
Preferred:
#LI-Hybrid
We hire for skills and capabilities, not just credentials 6 if this role excites you, but doesn 2 perfectly match your resume, we encourage you to apply anyway.
Devens - MA - US: $234,200 - $283,796
Madison - Giralda - NJ - US: $218,880 - $265,235
New Brunswick - NJ - US: $218,880 - $265,235
Princeton - NJ - US: $218,880 - $265,235
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 6 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 6 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. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year 2 Day.
U.S.-based job seekers can explore full benefit offerings athttps://careers.bms.com/benefits
How We Work
Where you work matters 6 because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at
