…Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, ...

…Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) ...

…Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system. Ensure alignment ...

…for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP ...

…for leading a team of microbiology data reviewers supporting the reviewing microbiology data and documentation generated from the Environmental Monitoring program, ...

…for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. ...

…Leads, directs, coaches and develops a holistic, effective training program for all plant functions and personnel that support daily clinical production and ...

…Supervises an effective maintenance team that supports daily production of a CAR-T manufacturing facility. Maintains safety standards and training in the department; ...

…Prepares and reviews documentation independently. Prepares and reviews documentation independently. Responsible for QC sample and retain management. Knowledge and ...

…Acts as the subject matter expert (SME) for 21 CFR Parts 210, 211, 11, EU Annex 11 among others. Works with above plant functions to successfully implement and ...