Description

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 on-the-job 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

- A minimum of a Bachelor Degree in Engineering, Science or equivalent technical discipline is required.
- A minimum of 3-4 years of experience in Quality Assurance related to manufacturing is required.
- Experience in method development, cell banking, or Research & Development is preferred  
- Experience working with cell therapy is preferred  
- Knowledge of cGMP regulations and FDA/EU guidance is required.  
- Knowledge of Good Tissue Practice is preferred.  
- Excellent written and oral communication skills are required.