Supervisor Microbiology

Position Title:
QC Supervisor Micro Lab, CAR-T Europe

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QC Supervisor Micro Lab for the CAR-T hub in Europe.

The position will be based in Beerse Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system.

They are created from the patients' own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The QC Supervisor Micro Lab, CAR-T Europe is responsible for the implementation and execution of the Quality Control programs within the QC Micro Lab for CAR-T and manages a team of QC analysts.

The QC Supervisor Micro Lab is responsible for the timely release of the micro related tests out of the CAR-T product manufacturing in the Ghent facilities.

Quality Leadership:

• Lead the Micro QC team by supporting, coaching and developing team members in reaching quality, business and personal objectives
• Establish and maintain effective working relationships with business and quality partners to ensure alignment of objectives and deliverables
• Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance

Operational Quality performance:

• Manages a team of analysts within the Micro QC department based on assigned work, direction, coaching and developing capabilities.
• Responsible for test method verification, qualification and/or transfer activities in the Micro QC lab
• Responsible for the environmental, product release, and stability testing of micro related tests.
• Provides expertise in troubleshooting of complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
• Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in onthejob training requirements.
• Collaborates with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Qualifications:

Experience and Skills:

• A minimum of a Bachelor Degree in Science or equivalent technical discipline is required.
• A minimum of 34 years of experience in Quality Control related to manufacturing is required.
• Experience working with cell therapy is preferred
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• Excellent written and oral communication skills are required.

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