MSAT Validation & Lifecycle Lead – Cell Therapy

Bristol Myers Squibb; Leiden; On-site; EUR 120,000 - 140,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation & LCM to lead validation activities at our Leiden Cell Therapy Facility. You will oversee aseptic validation, lifecycle management changes and collaborate with site engineers and cross-functional teams.

The role requires a strong background in cGMPs, 8+ years in biopharma operations, and a track record of regulatory readiness. A hybrid/onsite approach with a focus on site collaboration is expected.

Qualifications

• Bachelor’s degree in science, engineering or related discipline; advanced degree preferred.
• 8+ years’ experience in biopharmaceutical operations or equivalent.
• Knowledge of cGMPs and biopharmaceutical regulations.

Responsibilities

• Lead validation activities for new products or processes at the Leiden facility.
• Oversee Process Validation activities including APS/APV and PPQ.
• Perform data analysis and prepare protocols/reports for validation studies.
• Design and execute test plans and risk mitigation investigations.
• Interface with process engineers as validation SME.
• Support lifecycle management changes and site change controls.
• Ensure cGMP compliance and readiness for regulatory inspections.
• Promote continuous improvements to reduce risks and costs.
• Participate in cross-functional and multi-site teams.

Skills

cGMP regulations

Facility design & validation

Lifecycle changes

Audits & PLIs

Communication skills

Education

Bachelor’s degree in science/engineering/biochemistry or related discipline

Advanced degree preferred

Job description

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation & LCM to lead validation activities at our Leiden Cell Therapy Facility. You will oversee aseptic validation, lifecycle management changes and collaborate with site engineers and cross-functional teams.

The role requires a strong background in cGMPs, 8+ years in biopharma operations, and a track record of regulatory readiness. A hybrid/onsite approach with a focus on site collaboration is expected.