MSAT Validation & Lifecycle Lead, Leiden

Bristol-Myers Squibb; Leiden; Hybrid; EUR 95,000 - 135,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation & LCM to lead validation activities at the Leiden Cell Therapy Facility, guiding aseptic validation, process transfers and lifecycle management.

You will collaborate with process engineers and cross-functional teams to ensure compliance with cGMPs and regulatory expectations while driving continuous improvement and site change controls.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline required; advanced degree preferred.
• Minimum 8 years’ experience in biopharmaceutical operations or its equivalent.
• Knowledge of cGMPs and international biopharmaceutical regulations.
• Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs).
• Excellent verbal/written communication and ability to influence at all levels.

Responsibilities

• Lead validation activities for new products or processes at the Leiden CTF.
• Oversee CTF Process Validation activities including APS/APV and PPQ.
• Analyze data using statistics and prepare protocols/reports supporting validation and lifecycle management.
• Design and execute test plans and risk mitigation in investigations.
• Interface with process engineers and serve as MSAT SME on validation matters.
• Lead lifecycle management changes and support commissioning, qualification and validation of equipment/facilities.
• Own site Change Controls and contribute to risk assessments and qualification documents.

Skills

cGMP regulations

Clean room design

Process validation

Regulatory audits

Communication

Education

Bachelor’s degree in science/engineering

Advanced degree preferred

Job description

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation & LCM to lead validation activities at the Leiden Cell Therapy Facility, guiding aseptic validation, process transfers and lifecycle management.

You will collaborate with process engineers and cross-functional teams to ensure compliance with cGMPs and regulatory expectations while driving continuous improvement and site change controls.