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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) 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:

• Masters 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

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