Manager MSAT Validation & LCM, Cell Therapy

Bristol-Myers Squibb; Netherlands; On-site; EUR 90,000 - 120,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation &LCM to provide process validation and lifecycle management support to the Leiden Cell Therapy Facility (CTF). The role leads validation activities for facility, processes and aseptic operations, including tech transfers.

The ideal candidate will bring deep cGMP knowledge, experience in validation and lifecycle changes, and a proven ability to work with audits and cross-functional teams to ensure compliance and continuous

Qualifications

• Proficient in cGMPs 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 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 facility.
• Responsible for CTF Process Validation activities including APS/APV and PPQ.
• Performs data analysis, including statistics, and prepares protocols/reports/summaries.
• Design and execute test plans and other risk mitigation exercises as part of investigations.
• Interface with process engineers and serve 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/Lead facility and process risk assessments and author qualification/validation documents.
• Support investigations and global change controls as required.
• Ensure safe and compliant cGMP operations and inspection readiness as SME.
• Identify and drive continuous improvements to reduce risks, costs, lead times.
• Serve as MSAT representative on cross-functional and multi-site teams.
• Build and maintain strong inter-team relationships to achieve goals.
• Support MSAT management in productivity and financial goals with the cross-functional team.
• Participate in routine plant operating meetings.

Skills

cGMP knowledge

Regulatory experience

Facility/clean room design

Process validation

Lifecycle management

Audits & inspections

Communication skills

Education

Bachelor's degree in science or engineering

Job description

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation &LCM to provide process validation and lifecycle management support to the Leiden Cell Therapy Facility (CTF). The role leads validation activities for facility, processes and aseptic operations, including tech transfers.

The ideal candidate will bring deep cGMP knowledge, experience in validation and lifecycle changes, and a proven ability to work with audits and cross-functional teams to ensure compliance and continuous