Sr. Director, Aseptic Process & Design
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 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 EquipmentandUtilities
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:Bachelors degree in Microbiology Biology Biochemistry Pharmaceutical Sciences Chemical Engineering or related scientific discipline
Experience
12 yearsof progressive experience in pharmaceutical manufacturingquality 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 skillsable 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 QAMS&TOperations Engineering and External Partners
Strategic thinker with the ability toscale enterprise standardsacross a diverse global network
Willingness totravel domestically and internationally(estimated 2535%) 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 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 Process & Design
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
