Sr. Director, Aseptic Process & Design

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

Benefits offered by this job

Wellbeing benefits

Retirement plan

Insurance (medical, dental, vision)

Flexible Time Off

11 paid holidays

Job summary

Bristol Myers Squibb is seeking a senior expert to shape enterprise sterility and microbial control across global manufacturing sites. The role involves defining strategies, leading regulatory interactions, and guiding CAPA processes to prevent contamination in sterile operations.

Qualified candidates will have extensive experience in aseptic process design, environmental monitoring, and regulatory submissions, with strong cross-functional leadership and global coordination capabilities.

Qualifications

• Bachelor's degree in Microbiology or related field.
• 12+ years in pharmaceutical manufacturing/quality/sterility assurance.
• Experience with aseptic process design, environmental monitoring, and regulatory submissions/inspections.

Responsibilities

• Define and maintain enterprise sterility and microbial failure models.
• Own the enterprise contamination control strategy aligned with regulatory expectations.
• Develop risk assessment methodologies and tools for global sites.
• Lead or support CAPA development for systemic contamination trends.

Skills

Risk assessment

Regulatory inspections

Cross-functional leadership

Aseptic processing

Education

Bachelor's degree in Microbiology

Tools

APS design

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 Risk Framework & Taxonomy Define andmaintaintheenterprise sterility and microbial failure modelibrary, including risk classification taxonomy, contamination event typology, and risk-based sampling strategies
• Establish and own theenterprise-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 thatimpactsterility assurance across the BMS network Serve as the enterprise escalation point for complex microbial and contamination-related quality eventsaround 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 trendsaround Facilities, Equipment,andUtilities
• 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 enterprisesmoke 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 standardsfor sterilization and microbial control, including terminal sterilization, filtration sterilization, and SIP/CIP processes Provideexpertiseand author standards forsterilization of Single-Use Technologies (SUT) and consumables, including extractables/leachablesconsiderations 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 controlexpertiseto 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 Conducthygienic practice reviewsof 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 Provideaseptic and microbial control by-design oversightfor facility, utility, equipment, and process changes — for both sterile and non-sterile manufacturing sites Provide subject matterexpertiseat external manufacturers when investing innew technologies Engage at the design review stage of capital projects, cleanroom construction/renovation, and major equipment installations to embed contamination control principles frominception Accountable for reviewing and approving change controls with microbial or sterility assurance impactduring design or critical changes in a facility Drive innovation in aseptic processing technologies including advanced barrier systems, automation and digital/AI enabled environmentalmonitoring and trend analytics

Qualifications & Experience

• Education Required:Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
• Experience 12+ yearsof progressive experience in pharmaceutical manufacturing,quality, sterility assurance, or microbiology within a regulated GMP environment 7+ yearsof senior/leadership experience with direct accountability for sterile manufacture Demonstratedexpertiseinaseptic process design, environmental monitoring, contamination control strategy, and regulatory submissions/inspections Experience withSingle-Use Technologies (SUT), biologics, or complex drug product manufacturing strongly preferred Proventrack recordleadingcross-functional teamsacross global, matrixed organizations
• Technical Expertise Deep knowledge ofEU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11, USP <1116>, <797>, and other relevant compendia Proficiencyinrisk management tools(FMEA, fault tree analysis, contamination control risk assessments) Strong command ofAPS/media fill design, smoke visualization studies, sterilization science, and WFI/PW/utility microbiology Familiarity with hygienic engineering standards (ASME BPE, EHEDG)
• Leadership & Competencies Exceptionalscientific communication skills—able to translate complex microbiological risk into clear, actionable guidance for diverse audiences including senior leadership and regulators Strongregulatory inspection acumenwithdemonstratedexperience 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 toscale enterprise standardsacross a diverse global network Willingness totravel 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

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

Benefits:

• 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

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.

R1606480 : Sr. Director, Aseptic Process & Design Data Privacy Link

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.

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.