Sr. Director, Aseptic Operational Support

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

• Translate performance data and risk signals into actionable strategies and executive-level insights

Cross-Site Harmonization & Knowledge Management
• Drive cross-site harmonization of aseptic and microbial control practices across the global manufacturing network

• Build,facilitate, and sustain a Community of Practice (CoP) for sterility assurance and contamination control, enabling knowledge sharing, peer learning, and best practice dissemination

• Lead enterprise knowledge management initiatives capturing learnings from deviations, audits, and industry trends and converting them into prevention actions and training content

• Champion a culture of continuous improvement and scientific rigor across both sterile and non-sterile manufacturing communities

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

• Provide aseptic and contamination controlexpertisein technology transfers, PPQreadinessand commercialization activities acrossinternal and external manufacturing sites

• Lead governance andoversight of high-risk, systemic, or cross-site contamination events including Subject Matter Expert (SME) impact assessments, root cause investigations, and CAPAs

• Provideauthoritative technical guidance on sterile and non-sterile contamination events, ensuring scientifically sound and regulatory-aligned conclusions

• RepresentBMS as the senior technical voice in regulatory inspections, agency interactions, and industry forums related to aseptic operations and microbial control

Environmental Monitoring Program Ownership
• Define enterprise environmental monitoring (EM) program requirements, including:

• Alert and action limit standards

• Sampling plan design and review

• Monitoring frequency standards

• Personnel sampling requirements

• Ensure EM program requirements are consistently applied across sterile manufacturing environments and extended appropriately to relevant non-sterile environments

• 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
• Monitor and trend enterprise CMO aseptic and microbial control performance indicators and risk signals; capture anddisseminatelearnings as enterprise-level prevention actions

• Provides technical input for CMO escalations, deviations, investigations, and technology transfers involving aseptic or microbial control considerations

• Conduct risk-tiered CMO assessments for aseptic practices and microbial control,establishingdifferentiated oversight models based on risk profile and performance history

• Design and implement standardized CMO oversight tools, dashboards, and decision trees to enable consistent and data-driven monitoring of aseptic and microbial control performance across the CM

Gowning, Personnel Flow & Aseptic Facility Design Guidance
• Govern andprovideexpert guidance on gowning qualification programs and gowning sequence standards across aseptic and controlled manufacturing operations

• Defineoptimalpersonnel, material, and waste flow strategies for aseptic and controlled manufacturing environments to minimize contamination risk

• 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

• Minimum8 30 yearsin senior leadership roles with enterprise-level accountability for quality, compliance, or regulatory strategy

• 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)

• Experience governingCMO/CDMO quality relationshipsand aseptic compliance requirements

• Track recordof successfully leading enterprise-wideharmonization and change management programs

Skills & Competencies
• Enterprise thinking:Ability to translate site-level data into network-wide strategy and risk management decisions

• Technical depth:Recognized internal and external authority in aseptic sciences, contamination control, and environmental monitoring

• Executive communication:Skilled at distilling complex technical content for senior leadership, regulatory agencies, and external partners

• Change leadership:Ability to influence without direct authority across a complex, matrixed global organization

• Data fluency:Proficiencyinleveragingperformance dashboards, trend analytics, and KPIs to drive decisions

• Collaboration:Strong cross-functional partnership skills across Quality, Operations,MS&T,Regulatory, and Supply Chain

Preferred:
• Advanced degree (M.S. or Ph.D.) inMicrobiologyor a related field

#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.

Compensation Overview:

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