MSAT Validation & LCM Manager – Cell Therapy (Hybrid)

Bristol-Myers Squibb Co; Leiden; Hybrid; EUR 110,000 - 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, process validation, data analysis, and lifecycle management tasks essential to product supply.

Responsibilities include coordinating process engineers, managing change controls, and ensuring regulatory readiness, cGMP compliance, and continuous improvement across manufacturing operations.

Qualifications

• Proficient in cGMPs and biopharmaceutical/cell therapy regulations.
• Experience with facility/clean room design, validation and lifecycle changes.
• Excellent written and verbal communication; ability to influence at all levels.
• Experience with audits, including pre-licensure inspections (PLIs).

Responsibilities

• Lead validation activities for new products/processes at Leiden CTF.
• Oversee Aseptic Process Simulations/PPQ and lifecycle validation tasks.
• Prepare protocols, reports and summaries supporting validation studies.
• Coordinate with process engineers; serve as validation SME.
• Own site change controls and risk assessments; develop qualification documents.

Skills

cGMP knowledge

Validation leadership

Communication skills

Regulatory interaction

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. You will drive aseptic validation, process validation, data analysis, and lifecycle management tasks essential to product supply.

Responsibilities include coordinating process engineers, managing change controls, and ensuring regulatory readiness, cGMP compliance, and continuous improvement across manufacturing operations.