Sr. Director, Aseptic Operational Support
Job Location:
New Brunswick, NJ - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Bristol Myers Squibb our employees often ask Who are you working fora 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
Buildfacilitate 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 controlestablishingdifferentiated 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:Bachelors 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
Minimum810 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 1Part IV for Advanced TherapiesICH 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 OperationsMS&TRegulatory 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 if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.
Compensation Overview:
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 Years Day.
U.S.-based job seekers can explore full benefit offerings at 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 People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit 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.
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R: Sr. Director Aseptic Operational Support
Required Experience:
Exec
About Company
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more
