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About the role:
We are seeking a CAR-T Batch Monitoring Specialist to join our client's team. This role involves collaborating with CAR-T manufacturing and Quality teams to ensure timely batch processing and release. The successful candidate will be responsible for monitoring batch delays, maintaining digital case reports, and supporting new commercial launches. This position requires a strong background in CAR-T GMP manufacturing and technical operations, with a focus on quality and efficiency. The role offers an opportunity to work in a dynamic environment, contributing to the advancement of CAR-T therapies
Key responsibilities:
* Work closely with CAR-T manufacturing & Quality to identify early indications a batch may be delayed
* Assess and prioritize any issue for further alert, action or monitoring
* When a delay is confirmed, populate a specialized batch monitoring platform
* Provide excellent care to every delayed batch
* Maintain a digital case report for each patient batch requiring delay or release monitoring
* Assist in developing and continuously monitoring new manufacturing workflows for batches requiring delays
About you:
* Degree in Immunology, Molecular Biology, Bio-Pharmaceutical Manufacturing or equivalent field preferred
* 4 years of relevant work experience
* Fluency in Dutch and English required
* GxP Technical Operations, Quality or Manufacturing experience
* Proven work experience within a CAR-T GMP manufacturing setting
* Knowledge of performing tests using and interpreting data from f.e.: BAC-T sterility, Digital Drop PCR Methods, Automated cell counters...
📩 Interested? Apply now or send an e-mail to bo.schoonjans@akkodis.com so we can get in touch!