MSAT Validation & Lifecycle Lead – Cell Therapy

Bristol Myers Squibb; Leiden; Hybrid; EUR 90,000 - 140,000; 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. You will drive aseptic validation, PPQ, and lifecycle changes, interfacing with process engineers and ensuring compliance in a fast-paced biopharma environment.

You will guide investigations, risk assessments, and regulatory readiness while partnering with cross-functional teams to advance cell therapy programs and site improvements.

Qualifications

• Proficient in cGMPs and international biopharmaceutical regulations.
• Experience with facility/clean room design, process, equipment, automation, and validation.
• Experience in assessing and implementing lifecycle changes.
• Experience with internal and health authority audits, especially PLIs.
• Excellent verbal and written communication and influencing skills.

Responsibilities

• Lead validation activities for new products or processes at the Leiden Cell Therapy Facility.
• Own CTF process validation activities including APS/APV and PPQ.
• Perform data analysis with statistics; prepare protocols, reports, and summaries.
• Design and execute test plans and risk mitigations for investigations.
• Interface with process engineers and act as process validation SME.
• Lead site implementation of lifecycle management changes.
• Support equipment and facility commissioning, qualification and validation.
• Lead/own site Change Controls.
• Participate in facility and process risk assessments and author qualification/validation documents.
• Support investigations and global change controls as required.
• Ensure safe, compliant cGMP operations and inspection readiness; support regulatory inspections.
• Identify and drive improvements reducing risks, costs, lead times, scrap, and discrepancies.
• Serve as MS&T representative on cross-functional and multi-site teams.
• Build relationships across site and network to support lifecycle programs.
• Foster inter-team collaboration to achieve goals.
• Support MSAT management in productivity and financial targets with cross-functional teams.
• Participate in routine plant operating meetings.

Skills

cGMP regulatory knowledge

Facility/clean room design

Process validation

Audits & PLIs experience

Communication & influence

Education

Bachelor’s degree in science/engineering/biochemistry

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. You will drive aseptic validation, PPQ, and lifecycle changes, interfacing with process engineers and ensuring compliance in a fast-paced biopharma environment.

You will guide investigations, risk assessments, and regulatory readiness while partnering with cross-functional teams to advance cell therapy programs and site improvements.