Cell Therapy Process Engineering Manager

Bristol Myers Squibb

Leiden

On-site

EUR 120,000 - 180,000

Full time

9 days ago

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Job summary

Bristol Myers Squibb Netherlands is seeking a Manager Process Engineering to lead the 24/7 production of CAR-T cell therapy at the Leiden facility. You will manage the Process Engineering team, coordinating with Validation, MES/Automation, Manufacturing and Quality to ensure rapid, compliant, and cost-efficient delivery of high-quality products.

The role requires deep knowledge of cell therapy processes, cGMPs, lean manufacturing, and strong leadership to guide investigations, CAPAs, and

Qualifications

  • Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience.
  • Knowledge of Lean Manufacturing principles required.
  • Minimum of 8 years of experience in cGMP biologics manufacturing, preferably in cell therapy in manufacturing or MSAT roles

Responsibilities

  • Drive processes to monitor, analyze, and optimize end-to-end production, including equipment support and troubleshooting.
  • Lead investigations and deviations, ensuring compliance with quality systems.
  • Review and approve technical documentation (investigations, SOPs, batch records, reports) on time.
  • Provide on-site and on-call support during operations and shopfloor topics.
  • Guide implementation of change initiatives and process improvements.
  • Coordinate cross-functional collaboration across Manufacturing, Quality, and Supply Chain

Skills

Facility/clean room design
Cell therapy processes
Single-use technologies
cGMP regulations
Lean Manufacturing
People management
Strategic thinking
Troubleshooting

Education

Bachelor’s degree in science or engineering
Advanced degree preferred

Tools

Automation systems
Process Validation
MES systems
Documentation management

Job description

Bristol Myers Squibb Netherlands is seeking a Manager Process Engineering to lead the 24/7 production of CAR-T cell therapy at the Leiden facility. You will manage the Process Engineering team, coordinating with Validation, MES/Automation, Manufacturing and Quality to ensure rapid, compliant, and cost-efficient delivery of high-quality products.

The role requires deep knowledge of cell therapy processes, cGMPs, lean manufacturing, and strong leadership to guide investigations, CAPAs, and

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