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VOOR JANSSEN PHARMACEUTICA, ONDERDEEL VAN JOHNSON EN JOHNSON CAMPUS BEERSE, ZIJN WIJ OP ZOEK NAAR:
* Support the manual tracking of Chain of Custody / Chain of Identity for patient samples. * Engage in development of a Chain of Custody / Chain of Identity IT system. * Support the logistics for shipping CAR-T materials to / from clinical sites. * Help set up shipping instructions and SOP's for manufacturing and clinical supplies. * Partner with GCDO and CAR-T manufacturing sites in the coordination of apheresis and production schedules. * Conduct training at each clinical site and be present for the pack-out of FPI samples at each site.
Prior experience working in a clinical or commercial supply chain is required. Knowledge of cGMP's and Agency requirements for biopharmaceutical manufacturing is required.