Senior QA Associate Cryo Lab Weekend

Position Title: Senior QA Associate Cryo Lab Beerse CAR-T EMEA

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for a Senior QA Associate Cryo Lab to be located in Beerse.

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at J&J Innovative Medicine Supply Chain a member of Johnson & Johnsons Family of Companies we are recruiting a QA Associate Cryo Lab (M/F/X). 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 patients 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 constructed two CAR-T manufacturing centers in the Ghent area (Belgium) where CAR-T investigational medicinal and commercial CAR-T products are manufactured. The newly build Cryo Lab will be operated from the existing Janssen Beerse site to provide the manufacturing facilities of their patients starting material.

The QA Associate Cryo Lab works together with the QA Cryopreservation Manager 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.

You will be responsible for:

• Cooperate with the operational technology team and will assist in Quality Assurance 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 laboratory.

• Responsible for batch record review and release of the cryopreservation Apheresis products.

• Overview ofapplicableQuality Agreements and Standards.

• Document Control: Review and approve project-specific documents including protocols standard operating procedures (SOPs) batch records and validation reports.

• Assists the QA Cryopreservation Manager for the establishmentand implementationof Company-wide quality policies strategies and practices.

• Audits & Inspections: Prepare for and participate in internal and external audits and inspections. Lead audit response activities and implement corrective actions as necessary.

• Setting up and maintaining key performance quality indicators.

• Deviation Handling

Experience and Skills:

• A bachelor degree is required preferably in medicines (medical biology) laboratory sciences or a related discipline such as cell biology but this is not considered a must.

• Proficiency in English and Dutch (verbal and written) as well as good personal communication skills are required

• Interest or knowledge in cell therapies and oncology is a plus

• Previous experience in a GMP or GTP environment hospital or blood bank environment is a must by 5 years .

• Good documentation practices is a must.

• Soft Skills: Problem-solving mentality and ability to work effectively in cross-functional teams (teamplayer).

Must be open to a flexible work regime.

Training and qualification will be provided in a day shift to switch afterwards in a weekend shift rotation (1220% ) from 6AM until 18PM Saturday and Sunday.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.

• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process!

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