Senior MSAT Validation & Lifecycle Manager

Bristol-Myers Squibb; Leiden; On-site; EUR 110,000 - 160,000; Full time

Job summary

Bristol Myers Squibb Netherlands seeks a Manager, MSAT Validation & LCM to lead facility, process, and aseptic validation activities at the Leiden Cell Therapy Facility. You will drive validation programs for new products and process transfers, ensuring compliance with cGMP and regulatory expectations.

The role collaborates with process engineers, quality, and cross-site teams to execute risk assessments, change controls, and lifecycle management.

Qualifications

• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations.
• Experience in facility/clean room design, process, equipment, automation, and validation.
• Experience in assessing and implementing product lifecycle changes
• Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs)
• Excellent verbal/written communication skills and ability to influence at all levels
• A minimum of 8 years’ experience in biopharmaceutical operations or its equivalent is required.
• Advanced degree preferred.

Responsibilities

• Lead validation activities for new products or processes related to the facility.
• Responsible for CTF 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 and serve as validation SME.
• Lead lifecycle management changes and site change controls.
• Support equipment and facility commissioning, qualification and validation.
• Participate in risk assessments and authors qualification/validation documents.
• Ensure compliant cGMP operations and support regulatory inspections.

Skills

cGMP knowledge

Process validation

Lifecycle management

Audits

Communication

Biopharma operations

Education

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

Advanced degree preferred

Job description

Bristol Myers Squibb Netherlands seeks a Manager, MSAT Validation & LCM to lead facility, process, and aseptic validation activities at the Leiden Cell Therapy Facility. You will drive validation programs for new products and process transfers, ensuring compliance with cGMP and regulatory expectations.

The role collaborates with process engineers, quality, and cross-site teams to execute risk assessments, change controls, and lifecycle management.