Director Cellular Therapy Laboratory OLOL

The Director Cellular Therapy Laboratory will oversee all daytoday 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 CART cells and other cell therapy products and must ensure that these activities are compliant with FACT CUA NMDP CIBMTR HIPAA the FDA and other regulatory bodies.

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Responsible for all technical operations of the Laboratory
Must be accessible 7 days a week either onsite 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 CUA 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 chainofcommand management.
Ensures lab staff safety
Works with Laboratory Supervisor to provide oversight of lab techs eel! processing SOPs 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.)
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 Supervisors 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 m written documents
Must be able to understand complex documentation.
Must have training relevant to cell therapy stem cells CART cells cell culture flow cytometry and cryogenics
Training for plasma RBC and volume reduction required

Other Duties as assigned

• Experience: Five (5) years of relevant experience
• Education: Bachelors in Life Science
• License and Certification: LSBME CLSG or CLSS
• Skills and Abilities: effective communication customer service interpersonal active listening technology and software