Sr. Director, Aseptic Operational Support

Bristol-Myers Squibb; New Brunswick (NJ); On-site; USD 219,000 - 265,000; Full time

Job summary

Bristol Myers Squibb in New Jersey seeks a Sr. Director of Aseptic Operational Support to lead enterprise sterility assurance, contamination control, and environmental monitoring across manufacturing sites including New Brunswick and Princeton.

You will drive governance, strategy, and data-driven decisions to minimize risks and ensure regulatory readiness. The role requires deep regulatory expertise, strong leadership, and a track record of transforming enterprise-wide aseptic programs within

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
• 15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
• Minimum 8–10 years in senior leadership roles with enterprise-level accountability for quality, compliance, or regulatory strategy
• Deep experience working in manufacturing facilities across multiple manufacturing modalities, including small molecule, biologics, cell therapy, or gene therapy
• Demonstrated expertise in global 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 supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent)

Responsibilities

• Govern enterprise aseptic and microbial control practices, including 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 thresholds for escalation of contamination events across sterile and non-sterile sites
• Establish and own enterprise-wide policies, standards, and procedures governing aseptic operations, environmental monitoring, and microbial control programs
• Define the enterprise aseptic, microbial control, and sterility assurance roadmap with short- and long-range strategies
• Establish KPIs and performance monitoring to measure program effectiveness, site compliance, and continuous improvement
• Lead enterprise trend detection and risk signal analysis across sterile and non-sterile environments
• Translate performance data into actionable executive insights
• Drive cross-site harmonization of aseptic practices across the global network
• Build and sustain a Community of Practice for sterility assurance and contamination control
• Lead knowledge management initiatives from deviations, audits, and industry trends into prevention actions
• Champion continuous improvement and scientific rigor across manufacturing communities
• Serve as enterprise technical authority for sterility assurance, contamination control, aseptic processing, and microbial risk management
• Provide aseptic expertise in technology transfers, PPQ readiness, and commercialization across sites
• Lead governance and oversight of high-risk contamination events with SME impact assessments and CAPAs
• Provide authoritative guidance on sterile and non-sterile contamination events for regulatory alignment
• Represent BMS in regulatory inspections and industry forums on aseptic operations and microbial control
• Define EM program requirements and monitoring standards
• Ensure EM standards are applied across sterile environments and extended to non-sterile environments
• Lead EM standard modernization aligned with regulatory expectations
• Monitor CMO aseptic and microbial control performance indicators and risk signals
• Provide input for CMO escalations, deviations, investigations, and technology transfers
• Conduct risk-tiered CMO assessments for aseptic practices
• Design standardized CMO oversight tools and dashboards
• Govern gowning qualification programs and gowning sequence standards
• Define personnel, material, and waste flow strategies to minimize contamination
• Support facility design reviews and cleanroom classification initiatives

Skills

Enterprise thinking

Technical depth

Executive communication

Change leadership

Data fluency

Collaboration

Education

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline

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

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 control expertise in technology transfers, PPQ readiness and commercialization activities across internal and external manufacturing sites
• Lead governance and oversight of high-risk, systemic, or cross-site contamination events — including Subject Matter Expert (SME) impact assessments, root cause investigations, and CAPAs
• Provide authoritative technical guidance on sterile and non-sterile contamination events, ensuring scientifically sound and regulatory-aligned conclusions
• Represent BMS 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 — Selection Process, Qualification & Ongoing Governance

• Monitor and trend enterprise CMO aseptic and microbial control performance indicators and risk signals; capture and disseminate learnings 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, establishing differentiated 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 and provide expert guidance on gowning qualification programs and gowning sequence standards across aseptic and controlled manufacturing operations
• Define optimal personnel, 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
• Minimum8–10 yearsin senior leadership roles with enterprise-level accountability for quality, compliance, or regulatory strategy
• Deep experience working in manufacturing facilities across multiple manufacturing modalities, includingsmall molecule, biologics, cell therapy, or gene therapy
• Demonstrated expertise inglobal 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 record of successfully leading enterprise-wideharmonization and change management programs

Preferred

• Advanced degree (M.S. or Ph.D.) in Microbiology or a related field
• #LI-Hybrid

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:Proficiency in leveraging performance dashboards, trend analytics, and KPIs to drive decisions
• Collaboration:Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain

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 – 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. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – 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 https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.