Associate Director, Aseptic & Sterile Process Engineering
Bristol Myers Squibb
August 13, 2026
Remote friendly (Devens, MA)
United States
Operations
Position Summary
- Serve as technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy.
Duties/Responsibilities
- Act as technical authority for aseptic/sterile processing strategy in an advanced automated environment.
- Lead scientific, risk-based justifications for high-grade aseptic manufacturing classification.
- Partner with Quality, Regulatory, Engineering, and SMEs to align on strategy, execution, and readiness.
- Ensure strategies are inspection-ready for commercial filings/approvals; support audits and regulatory inspections; develop defensible regulatory narratives.
- Own and lead Aseptic Process Simulation (media fill) strategy, execution, investigation, and lifecycle management; design APS for automated/robotic and closed/novel material flows.
- Define and maintain integrated contamination control and microbial strategy; align environmental monitoring, cleaning, and qualification; evaluate emerging methodologies.
- Collaborate with automation/equipment/process development to incorporate aseptic principles; advise on aseptic risks for advanced automation; mature robotic aseptic operations and sterile connection technologies.
- Lead via technical expertise and influence; facilitate cross-functional alignment; use data-driven decision-making.
Qualifications
Required:
- Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or related field.
- 8+ years in pharmaceutical/biologics/cell and gene therapy manufacturing.
- Hands-on aseptic processing/sterile manufacturing experience.
- Contamination control, environmental monitoring, and cleanroom qualification experience.
- Direct experience leading/supporting APS (media fills).
- Experience supporting regulatory inspections, commercial readiness, or technology transfer.
Preferred:
- Master’s/PhD in relevant discipline.
- Experience with automated/robotic/closed manufacturing systems.
- Familiarity with mechanical sterile connectors/advanced aseptic interfaces.
- Experience with external equipment vendors/technology developers.
- Strong written/verbal communication; matrix influence.
Compensation/Benefits (explicit)
- Devens, MA (US): $170,650–$206,793.
- Health coverage, wellbeing support, 401(k), disability/life/insurance options.
- Paid time off (details vary by employee type/location).
Application instructions
- Apply even if your experience doesn’t perfectly match the requirements.
- Serve as technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy.
Duties/Responsibilities
- Act as technical authority for aseptic/sterile processing strategy in an advanced automated environment.
- Lead scientific, risk-based justifications for high-grade aseptic manufacturing classification.
- Partner with Quality, Regulatory, Engineering, and SMEs to align on strategy, execution, and readiness.
- Ensure strategies are inspection-ready for commercial filings/approvals; support audits and regulatory inspections; develop defensible regulatory narratives.
- Own and lead Aseptic Process Simulation (media fill) strategy, execution, investigation, and lifecycle management; design APS for automated/robotic and closed/novel material flows.
- Define and maintain integrated contamination control and microbial strategy; align environmental monitoring, cleaning, and qualification; evaluate emerging methodologies.
- Collaborate with automation/equipment/process development to incorporate aseptic principles; advise on aseptic risks for advanced automation; mature robotic aseptic operations and sterile connection technologies.
- Lead via technical expertise and influence; facilitate cross-functional alignment; use data-driven decision-making.
Qualifications
Required:
- Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or related field.
- 8+ years in pharmaceutical/biologics/cell and gene therapy manufacturing.
- Hands-on aseptic processing/sterile manufacturing experience.
- Contamination control, environmental monitoring, and cleanroom qualification experience.
- Direct experience leading/supporting APS (media fills).
- Experience supporting regulatory inspections, commercial readiness, or technology transfer.
Preferred:
- Master’s/PhD in relevant discipline.
- Experience with automated/robotic/closed manufacturing systems.
- Familiarity with mechanical sterile connectors/advanced aseptic interfaces.
- Experience with external equipment vendors/technology developers.
- Strong written/verbal communication; matrix influence.
Compensation/Benefits (explicit)
- Devens, MA (US): $170,650–$206,793.
- Health coverage, wellbeing support, 401(k), disability/life/insurance options.
- Paid time off (details vary by employee type/location).
Application instructions
- Apply even if your experience doesn’t perfectly match the requirements.