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Job Function:

Supply Chain Engineering:

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium

Job Description:

MBR Change Management Lead (m/f/d)Location: Ghent – CAR-T

Job type: Full-time

We are seeking a dynamic and experienced MBR Change Management Lead to join our Manufacturing Science & Technology (MSAT) organization. In this role, you will be responsible for governance of Master Batch Records (MBR)/eMBR and associated change control processes across clinical and commercial CAR-T manufacturing.

This role will ensure that the batch record lifecycle is compliant and aligned with evolving business needs. The role will also includes leading cross-functional projects to support product lifecycle management and continuous improvement ideas.

The ideal candidate brings strong expertise in pharmaceutical manufacturing, cell therapy and structured project management within a regulated environment.

Key Responsibilities:

• Support the lifecycle of the clinical and commercial supply of CAR-T products.

• Lead cross-functional project teams (including Operations, MSAT, Quality, IT) on MBR governance & deliver change initiatives on time and in compliance with GMP requirements.

• Own and oversee MBR/eMBR governance, ensuring compliance with global regulatory requirements.

• Develop and execute implementation strategies for introducing new projects and process updates into MBR/eMBR systems.

• Coordinate and align MBR updates and implementation timelines across departments and manufacturing sites.

• Acts as primary liaison between business units and the Manufacturing Execution System (MES) to ensure seamless integration of process changes.

• Support internal and regulatory inspections by providing subject matter expertise on MBR governance and change management processes.

Qualifications:

• Master’s degree in Biotechnology, Chemistry, Engineering, Life Sciences, or a related scientific discipline.

• Minimum 5 years of experience in the pharmaceutical or biopharmaceutical industry.

• Experience in GMP-regulated clinical and/or commercial manufacturing environments.

• Strong knowledge of change control processes and document lifecycle management.

• Experience with manufacturing and supply chain systems such as PAS-X MES, SAP, and eLIMS.

• Strong communication skills with the ability to engage effectively across all organizational levels.

• Strong organizational and prioritization skills in a fast-paced and evolving environment.

• Excellent teamwork and ability to influence stakeholders and build strong collaborative relationships in a global organization

Required Skills:

Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection