Cell Therapy Process Engineer | Tech Transfer & Manufacturing

Bristol Myers Squibb; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Process Engineer to support technology transfer and production of CAR-T products for global clinical trials and commercial supply, based in Leiden. You will act as the process SME, collaborating with Development, Manufacturing and Quality teams to ensure rapid, flawless, compliant, and cost-efficient delivery of quality medicines.

This role requires shifting work to cover ongoing manufacturing campaigns, with occasional travel for training.

Qualifications

• Bachelor's degree in science or engineering (advanced degree preferred).
• 3+ years of biopharmaceutical manufacturing support experience.
• Knowledge of facility/clean room design, process design or equipment, automation.
• Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies.
• Experience with the start-up, process transfer or set up of the new manufacturing facilities.

Responsibilities

• Monitor, analyze, and optimize end-to-end production processes.
• Provide input on process deviations during manufacturing.
• Prepare and approve technical documents (investigations, changes, SOPs, batch records, reports).
• Collaborate with Manufacturing Operations on Shop Floor and Front Line Support during production campaigns.
• Provide prompt input on resolution of events in manufacturing and be responsible for troubleshooting.
• Support change initiatives and implement process improvements; own change controls and MSAT impact assessments.
• Participate in initiatives to ensure safe and compliant cGMP operations.
• Interact with SMEs in the BMS Cell Therapy network to exchange lessons learned.
• Participate in processes being technology transferred into the Leiden Cell Therapy Facility.
• Ability to work in shifts to continuously support manufacturing operations.
• Interact with local teams including MSAT MES, MSAT PDDA, Manufacturing Operations, Quality Assurance and Supply Chain.
• Actively support regulatory inspections as process SME when required.
• Collaborate with cross-functional teams for data collection and interpretation.
• Work with Engineering/Maintenance on new technology and equipment related to production.

Skills

MSAT experience

Process engineering

Single-use technologies

GxP knowledge

Technical writing

Education

Bachelor's degree in science or engineering

Job description

Bristol Myers Squibb Netherlands is seeking a Process Engineer to support technology transfer and production of CAR-T products for global clinical trials and commercial supply, based in Leiden. You will act as the process SME, collaborating with Development, Manufacturing and Quality teams to ensure rapid, flawless, compliant, and cost-efficient delivery of quality medicines.

This role requires shifting work to cover ongoing manufacturing campaigns, with occasional travel for training.