Full TimeDays8 Hours Monday-FridayUnder the direction of the Pediatric Cellular Therapy Laboratory (PCTL) Senior Supervisor, the Clinical Lab Scientist Supervisor has leadership responsibility and appropriate authority for administrative and fiscal functions as assigned. Supervises employees in highly technical sub-specialty area. Directly oversees all the technical operations of the laboratory, enforcing standard operating procedures and research methods. Responsible for laboratory meeting quality assurance standards. PCTL comply with the Foundation for the Accreditations of Cellular Therapy (FACT) standards and applicable FDA regulations including good tissue practices and good manufacturing practices.
Supervise operations for Processing and QC Sections, as applicable, in support of both standard-of-care hematopoietic stem cell transplant and clinical trials. In collaboration with the PCTL Senior Supervisor and under the oversight of Lab Director, has the primary responsibility of coordinating activities related to routine production and quality control of cell therapy products. Routine responsibilities include overseeing training/competency and monitoring the work performance of technical staff, troubleshooting and resolving technical problems, ensuring that required equipment, reagents, supplies, and staffing are available for production activities, timely verification of patient/batch record completion and communication of results, supporting new process development and quality studies, and assurance that laboratory operation follows internal SOPs and complies with applicable regulatory/accreditation requirements.

The final salary and offer components are subject to additional approvals based on UC policy.

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• Bachelor’s degree in related area and / or equivalent experience / training.
• Maintains current knowledge of laboratory concepts, new methodologies and advances in the field of specimen processing, automation, and procedures. Ability to apply principles in a clinical laboratory setting.
• Interpersonal skills to independently convey information with authority, handle highly sensitive matters and interact with high level contacts from other organizations.
• Demonstrated superior theoretical knowledge, technical judgment and skills and the ability to work with a minimum supervision.
• Assumes responsibilities for keeping abreast of technical developments through current literature review.
• Thorough knowledge in the fields of Cellular Therapy Processing and Storage and in Immunology.
• Good Technical and Teaching Skills.
• Ability to make sound decisions and good judgment.
• Must have high level of awareness for unusual or abnormal results and good problem solving skills.
• Must produce accurate, complete, legible records of work performed.
• Recent experience in a clinical laboratory setting that handle cell therapy products using aseptic technique, knowledge of cGMP, cGTP and cell therapy product processing and cryopreservation.
• HPC cryopreservation using liquid nitrogen. Familiar with the reagents, materials, and procedures used in cryopreservation.
• Operation, maintenance and quality control of liquid nitrogen storage tanks.
• Familiar with the designing inventory system for patient’s HPC product and aliquot samples using liquid nitrogen storage tank.
• Operation and maintenance of Program Rate Freezer (PRF).
• Flow Cytometer analysis. This includes staining, acquisition and analysis of samples for CD34, CD3 and other cell markers. Familiar with maintenance and quality control of the flow cytometer machine.
• Experience in performing thawing of HPC products and the use of aseptic technique.
• Compliance issues in the PCTL laboratory : Donor eligibility, Process Control, Document and Records.
• Experience in proper Storage and Preservation of products.
• At least three (3) years of related experience.

• Prefer 5 years of recent MT/MLS/CLS or related experience.
• California Clinical Laboratory Scientist License as Generalist or specialized in assigned laboratory section. Eligibility requirements will be in compliance with current California Department of Public Health.

• Medical Technologist certification by the American Society of Clinical Pathology (MT-ASCP) or equivalent