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Operations

Cell Journey Advocate

  • Título Cell Journey Advocate
  • Función Operations
  • Sub función Strategic Sourcing/Logistics
  • Ubicación Turnhout, Antwerp, Belgium
  • Publicado
  • Identificación requerida (Req ID) 2206080252W
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Descripción

The Cell Journey Advocate is expected to provide expert technical input to relevant stakeholders supporting the patient’s T-cells from apheresis and cryopreservation through successful manufacturing and timely release. This comprehensive role is accountable for our cryopreservation facility as Responsible Person and will serve as the single point of contact for the Belgium inspectorate. In addition, the Cell Journey Advocate works directly with relevant batch stakeholders at the cell processing and manufacturing facilities applying helpful specialized influence at any step within the cryopreservation, manufacture, or release processes. You will serve as the ‘Voice of the Cells’ to the various internal groups, such as the CAR-T Batch Advocates, Medical Affairs, QC and CAR-T cryopreservation and Manufacturing teams (US and EU). Essential is your successful collaboration with a primary team of specialists
in Quality Assurance and Logistics. Cycle times will be improved as a direct result of your influence and input.

The successful candidate will be able to provide a specialized level of expertise around the Cell Therapy cellular starting materials and manufacturing during communication with hospital physicians, medical affairs and order specialists for any batch of CAR-T material. The responsibilities span leukapheresis through drug product release. You will collaborate with production team members to monitor and add influence for the resolution of any realized delays. The Cell Journey Advocate will be prepared upon short notice to communicate with the Belgium Inspectorate as well as with site physicians on compliance and batch delays, respectively.

Calificaciones

- 3-7 years CAR-T GMP manufacturing role; or
- 3-7 years CAR-T GxP Technical Operations or manufacturing experience
- An EU Medical Degree with relevant cellular therapy experience is a must-have
Preferred: Knowledge of Oncology/Immunology, cryopreservation of human blood cells, EU Tissue and
Cell Directives - PhD, Pharm D, Research RN

- 100% fluent in Dutch or French, business proficiency in English
- EU working permit desired; position based in Beerse or Ghent, Belgium
- Available within 12 hours to communicate with FAGG and sites as needed

- Comprehensive knowledge performing tests using and interpreting data from: Automated cell counters, Digital Drop PCR Methods, Multi-color flow cytometry, ELISA methods for cytokines, Cell Culture, BAC-T sterility, Mycoplasma PCR testing
- In-depth comprehension of the implication of any issue to the delivery of a delayed batch
- Self-starter, independent
- Energetic work ethic
- Empathic
- Relatability to all aspects of the cell processing teams
- A minimum of 25% on-site presence

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