Associate Director, Aseptic & Sterile Process Engineering
Bristol Myers Squibb
5 hours ago
On-site
Devens, MA
Operations
Position Summary
Associate Director, Aseptic & Sterile Process Engineering—technical leader for aseptic/sterile processing strategy supporting advanced, automated cell therapy manufacturing.
Responsibilities
- Serve as technical authority for aseptic/sterile processing strategy in an advanced automated environment.
- Lead scientific, risk-based justifications for high-grade aseptic manufacturing classification.
- Ensure strategies are inspection-ready; support internal audits and external regulatory inspections.
- Own and manage Aseptic Process Simulation (APS/media fill) strategy, execution, investigation, and lifecycle.
- Define/maintain integrated contamination control and microbial strategy; align environmental monitoring, cleaning, and qualification.
- Collaborate with automation/equipment teams to incorporate aseptic principles into system design; advise on aseptic risks of automation.
- Lead via technical influence and cross-functional collaboration; use data-driven decision making.
Qualifications
Required: BS in Engineering/Biotech/Pharma Sciences/Microbiology (or related); 8+ years in pharma/biologics/cell & gene therapy manufacturing; hands-on aseptic/sterile operations; contamination control, environmental monitoring, and cleanroom qualification; direct APS/media fill experience; experience supporting regulatory inspections/commercial readiness/technology transfer.
Preferred: MS/PhD; experience with automated/robotic/closed systems; sterile connectors/aseptic interfaces; vendor/technology developer experience; strong written/verbal communication across matrix.
Compensation/Benefits
Devens, MA, US: $170,650–$206,793. Health coverage; wellbeing support; 401(k), disability, life/accident insurance, and other protection benefits; Paid Time Off (flexible time off or vacation/holidays per site).
Associate Director, Aseptic & Sterile Process Engineering—technical leader for aseptic/sterile processing strategy supporting advanced, automated cell therapy manufacturing.
Responsibilities
- Serve as technical authority for aseptic/sterile processing strategy in an advanced automated environment.
- Lead scientific, risk-based justifications for high-grade aseptic manufacturing classification.
- Ensure strategies are inspection-ready; support internal audits and external regulatory inspections.
- Own and manage Aseptic Process Simulation (APS/media fill) strategy, execution, investigation, and lifecycle.
- Define/maintain integrated contamination control and microbial strategy; align environmental monitoring, cleaning, and qualification.
- Collaborate with automation/equipment teams to incorporate aseptic principles into system design; advise on aseptic risks of automation.
- Lead via technical influence and cross-functional collaboration; use data-driven decision making.
Qualifications
Required: BS in Engineering/Biotech/Pharma Sciences/Microbiology (or related); 8+ years in pharma/biologics/cell & gene therapy manufacturing; hands-on aseptic/sterile operations; contamination control, environmental monitoring, and cleanroom qualification; direct APS/media fill experience; experience supporting regulatory inspections/commercial readiness/technology transfer.
Preferred: MS/PhD; experience with automated/robotic/closed systems; sterile connectors/aseptic interfaces; vendor/technology developer experience; strong written/verbal communication across matrix.
Compensation/Benefits
Devens, MA, US: $170,650–$206,793. Health coverage; wellbeing support; 401(k), disability, life/accident insurance, and other protection benefits; Paid Time Off (flexible time off or vacation/holidays per site).