MSAT Validation & Lifecycle Lead, Cell Therapy

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

Job summary

Bristol Myers Squibb Netherlands in Leiden is seeking a Manager, MSAT Validation & LCM to lead validation activities for the Leiden Cell Therapy Facility. You will oversee aseptic validation, process performance qualifications and related data analyses, acting as a validation SME with process engineers.

You will drive lifecycle management changes, support equipment commissioning, and ensure cGMP compliance while coordinating with cross-functional teams to meet regulatory expectations.

Qualifications

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

Responsibilities

• Lead validation activities for new products or processes related to the Leiden facility.
• Responsible for CTF Process Validation activities including APS/APV and PPQ.
• Performs data analysis and prepares protocols/reports supporting validation studies and lifecycle management.
• Design and execute test plans and risk mitigation exercises related to validation studies.
• Interface with process engineers and act as validation SME.
• Leads site implementation of Lifecycle Management changes.
• Supports equipment and facility commissioning, qualification and validation.
• Leads/Owns site Change Controls.
• Participates in/Leads facility and process risk assessments and qualification/validation documents.
• Ensures compliant cGMP operations and readiness for regulatory inspections.

Skills

cGMP compliance

Facility/cleanroom design

Process validation

Lifecycle changes

Audits/PLIs

Communication skills

Education

Bachelor’s degree in science/engineering

Advanced degree preferred

Job description

Bristol Myers Squibb Netherlands in Leiden is seeking a Manager, MSAT Validation & LCM to lead validation activities for the Leiden Cell Therapy Facility. You will oversee aseptic validation, process performance qualifications and related data analyses, acting as a validation SME with process engineers.

You will drive lifecycle management changes, support equipment commissioning, and ensure cGMP compliance while coordinating with cross-functional teams to meet regulatory expectations.