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

…Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines. Assign investigations to team members ...

…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 ...

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

…for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and ...

…Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current ...