QC Supervisor Micro CAR-T

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Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
People Leader

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

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 has built two CAR-T manufacturing centers in the Ghent area (Belgium).

The QC laboratories are operated from the Janssen Beerse site.

The QC Supervisor Microbiology oversees the day-to-day planning & Quality Control activities for the QC Micro Release laboratory, ensuring GMP compliance, accuracy and timely release of the micro-related tests performed on the CAR-T drug product.

The QC Supervisor Microbiology manages a team of QC analysts and is responsible for interviewing, hiring, performance review, rewarding, disciplining employees, addressing complaints, resolving conflict and supporting internal and external audits. The supervisor carries out these responsibilities in accordance with the organization’s policies as well as with local, state and federal regulations and guidelines (including EMA, FDA, …)

Quality Leadership:


* Lead the Micro QC team (EM lab, Mycoplasma lab, Sterility lab, Growth promotion testing lab and Endotoxin lab) 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 QC micro analysts within the QC department based on assigned work, direction, coaching and developing capabilities.


* Sets testing priorities and manages work assignments


* Maintains individual training completion in a compliant state


* Evaluates performanc...