Sr. Director, Aseptic Process & Design

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 Risk Framework & Taxonomy

Define and  maintain  the   enterprise sterility and microbial failure mode library, including risk classification taxonomy, contamination event typology, and risk-based sampling strategies

Establish and own the   enterprise-wide contamination control strategy (CCS)   aligned with current regulatory expectations (EU Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10)

Develop and standardize risk assessment methodologies and tools used across global manufacturing sites

Risk Assessment Governance & Quality Oversight

Perform Global Microbial risk assessments of the internal sites and help build action plans with the sites to remediate risk.

Provide authoritative review and sign-off on quality decisions that  impact  sterility assurance across the BMS network

Serve as the enterprise escalation point for complex microbial and contamination-related quality events around Facilities, Equipment and Utilities

Technical Authorship & Regulatory Inspection Support

Author technical Business Technical Assessments (BTAs)   and develop robust investigation and inspection-ready materials in support of systemic microbiological issues

Serve as a key technical resource during regulatory inspections (FDA, EMA, PMDA, and others), providing expert testimony and documentation on aseptic process and microbial control matters

Lead or support CAPA development and effectiveness monitoring for systemic contamination trends around Facilities, Equipment, and Utilities

Aseptic Process Simulation (APS) & Media Fill Governance

Define and govern the enterprise APS/media fill strategy, including program design, intervention criteria, acceptance expectations, and performance governance. Partnering with aseptic teams at the sites.

Oversee the enterprise   smoke study program, including design, execution standards, and review of outcomes to confirm airflow behavior in critical zones

Establish qualification and requalification frameworks for aseptic filling operations

Manufacturing Process & Equipment Design Standards

Define manufacturing process and equipment design standards   for sterilization and microbial control, including terminal sterilization, filtration sterilization, and SIP/CIP processes

Provide  expertise  and author standards for   sterilization of Single-Use Technologies (SUT) and consumables, including extractables/ leachables  considerations and biocompatibility risk assessments

Provide hygienic equipment design leadership to Quality, Engineering, and MS&T teams, ensuring robust contamination control by design

Provide aseptic process and contamination control  expertise  to support Internal & External technology transfers

  Site Microbial Assessment Ownership

Own and coordinate the microbial assessment of internal manufacturing sites, ensuring consistent application of enterprise standards and identification of systemic risk areas

Conduct   hygienic practice reviews   of production environments and quality control test laboratories

Drive continuous improvement initiatives based on environmental monitoring trend data, contamination investigation findings, and industry benchmark intelligence

  By-Design Oversight for Changes & Capital Projects  

Provide   aseptic and microbial control by-design oversight   for facility, utility, equipment, and process changes, for both sterile and non-sterile manufacturing sites

Provide subject matter  expertise  at external manufacturers when investing in  new technologies

Engage at the design review stage of capital projects, cleanroom construction/renovation, and major equipment installations to embed contamination control principles from  inception

Accountable for reviewing and approving change controls with microbial or sterility assurance impact during design or critical changes in a facility

Drive innovation in aseptic processing technologies including advanced barrier systems, automation and digital/AI enabled environmental monitoring and trend analytics

Qualifications & Experience

Education

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

Experience

12+ years   of progressive experience in pharmaceutical manufacturing, quality, sterility assurance, or microbiology within a regulated GMP environment

7+ years   of senior/leadership experience with direct accountability for sterile manufacture

Demonstrated  expertise  in   aseptic process design, environmental monitoring, contamination control strategy, and regulatory submissions/inspections

Experience with   Single-Use Technologies (SUT), biologics, or complex drug product manufacturing strongly preferred

P roven  track record  leading   cross-functional teams   across global, matrixed organizations

Technical Expertise

Deep knowledge of   EU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11, USP , , and other relevant compendia

Proficiency  in   risk management tools   (FMEA, fault tree analysis, contamination control risk assessments)

Strong command of   APS/media fill design, smoke visualization studies, sterilization science, and WFI/PW/utility microbiology

Familiarity with hygienic engineering standards (ASME BPE, EHEDG)

Leadership & Competencies

Exceptional   scientific communication skills, able to translate complex microbiological risk into clear, actionable guidance for diverse audiences including senior leadership and regulators

Strong   regulatory inspection acumen   with  demonstrated  experience in health authority-facing roles

Collaborative, influential leadership style with the ability to drive alignment across QA, MS&T, Operations, Engineering, and External Partners

Strategic thinker with the ability to   scale enterprise standards   across a diverse global network

Willingness to   travel domestically and internationally   (estimated 25–35%) to manufacturing sites and third-party partners   

 

Preferred

Advanced degree (M.S. or Ph.D.) in Microbiology or a related field

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t 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 – 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  adastaffingsupport@bms.com . 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

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  TAEnablement@bms.com with 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.

R1606480 : Sr. Director, Aseptic Process & Design