Responsible for the Experimental Cellular Therapeutics laboratory, a translational core facility engaged in the generation and clinical production of cellular therapeutics for clinical trials. This includes the purification, transduction, and expansion of cells for genetically manipulated cellular products and other advanced therapeutic manipulations. Manages personnel and integrates efforts between faculty investigator laboratories, gene vector core and other cores, Children's GMP, LLC (CGL), Human Applications Laboratory (HAL), and Clinical Trials Administration. Creates new procedures to support PI-initiated clinical protocols and scale-up of products (vector and drug product) for manufacturing. Works with Quality Assurance to ensure compliance of all production activities with cGMP regulations, Code of Federal Regulations Title 21(21 CFR) part 210 and 211, current good tissue practice (cGTP) regulations (21 CFR part 1271), EMA, ICH, Foundation for the Accreditation of Cellular Therapies (FACT), and other applicable standards. Provides back-up for HAL director.
Ph.D. in a relevant field
Seven (7) years of related experience that must include the following: Five (5) years in a cellular therapeutics development lab or five years of postdoctoral experience with at least two (2) years in a cell processing facility required. Two (2) years of supervisory experience required