The Laboratory Director will oversee all day-to-day operations and all technical aspects of the Transplant and Cellular Therapy Laboratory which include the processing, cryopreservation, storage release, and thawing of high quality cellular therapy products including peripheral blood stem cells, bone marrow, umbilical cord blood, donor lymphocytes, CAR-T cells, and other cell therapy products and must ensure that these activities are compliant with FACT, CLIA, NMDP, CIBMTR, HIPAA, the FDA, and other regulatory bodies.
The Laboratory Director will develop new processes and procedures including in-house generation of CAR-T cells, ex vivo NK cell expansion, and other new processes and procedures as deemed necessary by the Clinical Program Director and Medical Director.
Must have excellent critical thinking skills to be able to troubleshoot any issue with processes and instrumentation.
Reports to: Transplant and Cellular Therapy Clinical Program Director and TCTL Medical Director
Duties and Responsibilities: •Responsible for all technical operations of the Laboratory
•Must be accessible 7 days a week either on-site or by phone to address any laboratory issues
•Have knowledge of cGTP and cGMP manufacturing
•Processes samples as needed
•Maintains current knowledge of the science surrounding these products, cellular therapy, and the regulatory environment
•Ensures compliance with all regulatory agencies including but not limited to FACT, CLIA, NMDP, CIBMTR, HIPAA, the FDA, and other regulatory bodies
•Must ensure the safety, potency and purity of cell therapy products
•Ensures cell therapy donor and recipient safety through proper chain-of-command management.
•Ensures lab staff safety
•Works with Laboratory Supervisor to provide oversight of lab techs, cell processing, SOP’s, lab maintenance and any issues that need attention
•Selects and validates any new equipment for the Laboratory
•Continuing education in all areas related to the cellular therapy products generated in the facility
•Ensures the facility is as technologically advanced as financially possible
•Reviews, approves and signs off on all technical processes and procedures in the laboratory.
•Reviews, approves and signs off on all Quality Control activities in the Laboratory
•Documents the review of all cell therapy products, equipment, consumables and testing
•Approves all purchasing for the laboratory
•Determines if cellular therapy products meet acceptance criteria
•Works closely with other TCT members (physicians, apheresis, coordinators, clinical trials, etc.)
•Interacts with Levine Children’s Hospital Pediatric Blood and Marrow Transplant Program
•Works with Clinical Trials Office staff on clinical trials involving cell therapy
•Maintains cell dose and engraftment data
•Provides adequate systems to manage, track and securely store product/patient files to meet or exceed institutional and external regulatory guidelines (FDA, FACT, and CAP).
•Develops and monitors expense budgets in the laboratory, authorizes expenditures. Assists in the development and implementation of capital budget and plans to control costs and improve department operations.
•Investigates trends and developments in laboratory practice; introduces new procedures.
•Ensures compliance with organizational policies for the laboratory. Interprets, executes, and recommends policy modifications.
•Provides leadership for educational programs for staff
•Assigns, monitors and supervises work to ensure compliance with departmental SOPs and applicable federal, state and regulating agencies requirements including health/safety and patient confidentiality.
•Works with Laboratory Supervisor to oversee and manage all safety/occurrence reports including investigations and remedial actions according to department and hospital guidelines with maintenance of documentation.
•Ensures the laboratory is prepared for all regulatory reviews and inspections including Joint Commission, FACT, FDA. Responds to findings according to department timelines and ensures remedial actions are implemented and maintained.
•Assists Laboratory Supervisor with development of new SOPs and implementation of procedures. Oversees Lab Supervisor’s work on SOP documentation, training and competency assessment according to department standards.
•Designs validation experiments as necessary to validate new processes or procedures or changes to current processes and procedures.
•Analyzes proficiency testing data
•Communicates regularly with the Clinical Program and Laboratory Medical Directors, providing notification of any problems or concerns
•Reviews contracts for new laboratory services
•Provides technical guidance to the facility with respect to any technical questions or new services
•Must be articulate and be able to communicate both orally and in written documents
•Must be able to understand complex documentation.
•Must have training relevant to cell therapy, stem cells, CAR-T cells, cell culture, flow cytometry and cryogenics
•Sepax training for plasma, RBC, and volume reduction required
Experience: Required: Five years of experience in clinical processing of cellular products with three years of supervisory or management experience in a cell therapy laboratory.
Education: PhD in the Life Sciences required (Cell Biology, Molecular Biology, Genetics, Immunology, Biochemistry preferred)