QA Associate Cryo Lab

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Associate for the CAR-T Cryo Lab in Europe.

The position will be based in Beerse.

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 and a new build Cryo Lab will be operated from the existing Janssen Beerse site.

The QA Associate Cryo Lab, CAR-T Europe works together with the QA Lead Cryo Lab and is accountable for the implementation of the overall EMEA CAR-T quality system in the Cryo Lab including compliance oversight, release of the cryopreserved apheresis material and deviation handling.

Responsibilities

• You will cooperate with the operational technology team and will assist for startup and subsequent QA oversight of the daily operations of all incoming fresh apheresis material for cryopreservation to support both clinical and commercial requirements in a new state of the art internal laboratory that is currently being built.
• You will assist in the batch record review and release of the cryopreservation Apheresis products.
• You will also oversee training of people.
• Provides QA oversight of applicable Quality Agreements and Standards.
• Assists the QA Lead Cryo Lab for the establishment and implementation of Companywide quality policies, strategies and practices.
• Assists the QA Lead Cryo Lab and Site QA Head for regulatory health authority inspections.
• Assists the QA Lead Cryo Lab in setting up and maintaining key performance quality indicators.

Qualifications:

• A bachelor degree, preferably in medicines, medical biology, laboratory sciences, or a related discipline such as cell biology is required
• Interest or knowledge in cell therapies and oncology is required
• Knowledge of the EU tissue and cell directives and the JACIE standards is preferential
• Previous experience in a GDP, GMP or GTP, hospital or blood bank environment is preferred
• Proficiency in English and Dutch (verbal and written), as well as good personal communication skills are required

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