Associate Director, Aseptic & Sterile Process Engineering
About The Position
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. The Associate Director, Aseptic & Sterile Process Engineering will serve as a technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy. This role is responsible for defining, justifying, and sustaining aseptic processing strategies that support regulatory approval and long‑term commercial manufacturing. The position requires deep technical expertise in aseptic processing combined with strong cross‑functional leadership and the ability to influence outcomes in a matrixed environment.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Director
