Associate Director, Aseptic & Sterile Process Engineering

Working with Us Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. Position Summary The Associate Director, Aseptic & Sterile Process Engineering serves as a technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy. The role defines, justifies, and sustains aseptic processing strategies that support regulatory approval and long‑term commercial manufacturing, requiring deep technical expertise in aseptic processing combined with strong cross‑functional leadership and the ability to influence outcomes in a matrixed environment. Duties / Responsibilities Serve as the technical authority for aseptic and sterile processing strategy for an advanced automated manufacturing environment. Lead the development of scientific and risk‑based justifications for high‑grade aseptic manufacturing classification. Partner with quality, regulatory, engineering, and technical subject‑matter experts to align on strategy, execution, and readiness. Ensure aseptic processing strategies are inspection‑ready to support commercial filings and regulatory approvals. Support internal audits and external regulatory inspections as a subject‑matter expert for aseptic processing and contamination control. Develop clear, defensible regulatory narratives for novel or non‑traditional manufacturing approaches. Own and lead Aseptic Process Simulation (media fill) strategy, execution, investigation, and lifecycle management. Design APS approaches that account for automated and robotic operations, closed or functionally closed processing, and novel material flows. Ensure APS success through robust system and process design. Define and maintain an integrated contamination control strategy aligned with advanced manufacturing technologies. Collaborate with microbiology and contamination control experts to ensure alignment of environmental monitoring, cleaning, and qualification strategies. Evaluate and incorporate emerging technologies or methodologies where appropriate. Collaborate closely with automation, equipment, and process development teams to ensure aseptic principles are incorporated into system design. Partner with external equipment suppliers and technology developers to evaluate and mature robotic aseptic operations and sterile connection technologies. Serve as a technical advisor for aseptic risks associated with advanced automation. Lead primarily through technical expertise, influence, and collaboration rather than direct authority. Facilitate alignment across cross‑functional stakeholders with differing priorities. Apply critical thinking and data‑driven decision making to resolve complex technical and organizational challenges. Qualifications Required Qualifications: Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related scientific or technical discipline. Minimum of 8 years of experience in pharmaceutical, biologics, or cell and gene therapy manufacturing. Significant hands‑on experience with aseptic processing and sterile manufacturing operations. Demonstrated experience with contamination control strategies, environmental monitoring, and cleanroom qualification. Direct experience leading or supporting Aseptic Process Simulations (media fills). Experience supporting regulatory inspections, commercial readiness, or technology transfer activities. Preferred Qualifications: Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline. Experience with automated, robotic, or closed manufacturing systems. Familiarity with mechanical sterile connectors or advanced aseptic interfaces. Experience working with external equipment vendors or technology developers. Strong written and verbal communication skills with the ability to influence across a matrixed organization. Additional Information This role requires the ability to work effectively in a fast‑paced, highly regulated environment and to manage complexity and ambiguity while delivering results. Compensation Overview (Devens – MA – US) Salary range: $170,650 – $206,793 (full‑time employee). Additional incentive cash and stock opportunities may be available. Final compensation will be decided based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work‑life benefits: Paid Time Off, flexible time off, unlimited paid sick time, volunteer days, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs. Annual Global Shutdown between Christmas and New Years Day. Eligibility for specific benefits may vary by job and location. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County, please visit for additional information. 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