Supervisor-Human Applications Lab: Cellular Therapy

The HAL supports the Department of Bone Marrow Transplantation and Cellular Therapy and Department of Oncology by providing products for patients enrolled in investigator-initiated clinical research protocols. The laboratory supports many clinical trials for cancer and genetic diseases, using primary hematopoietic graft products and genetically modified products for sickle cell disease and CAR T-Cell therapy applications. The Human Applications Laboratory is composed of two sections, the Quality Control Section providing product analysis by flow cytometry and product quality testing for sterility, and the Cell Processing Section providing cellular therapy product processing in accordance with good tissue practices and good manufacturing practices.

Job Description

In this role, the selected candidate will supervise the Cell Processing Section for processing activities in support of both standard of care hematopoietic stem cell transplant and translational clinical trials. This position reports to the HAL Manager and Director and is responsible for effectively leading the day-to-day technical activities related to routine production and quality control of cell therapy products. In collaboration with the Manager, Director, and Quality Assurance Unit, the Supervisor will assist in maintaining all regulatory requirements and adherence to the quality management program.

The position is on-site, Monday – Friday, primarily day shift (10:00 AM - 6:30 PM) with flexibility in working schedule to accommodate work, for extended hours, weekend and holiday coverage, when necessary.

Job Responsibilities:

• Supervise operations in support of both standard of care hematopoietic stem cell transplant and translational clinical trials.
• In collaboration with the laboratory manager and under the oversight of the HAL director, has primary responsibility for coordinating activities related to routine production and quality control of cell therapy products.
• Oversee training/competency and monitor work performance of technical staff.
• Provide troubleshooting expertise and resolve technical problems.
• Ensure required equipment, reagents, supplies and staffing are available for production activities.
• Perform timely verification of batch record completion and communication of results.
• Support new process development and quality studies.
• Assure laboratory operation follows internal SOPs and complies with applicable regulatory/accreditation requirements.

Skills / Knowledge / Abilities:

• High competency in cellular therapy processing procedures.
• Strong verbal and written communication skills
• Strong math skills
• Attention to detail
• Ability to organize and prioritize work assignments for self and others
• Ability and temperament to adapt to constantly changing conditions and variations in workload
• Foster teamwork to promote a positive work environment
• Supervisory experience
• Experience with flow cytometry is beneficial

Minimum Education:

Bachelor’s degree in an appropriate scientific field (such as Biology) is required

Minimum Experience:

A minimum of eight (8) years of laboratory experience with five (5) years of experience in hematopoietic stem cell processing or cellular therapy manufacturing required.

Licensure, Registration and/or Certification Required by SJCRH Only:

• Preferred: Certification as Medical Technologist / Medical Laboratory Scientist (ASCP, NCA, or AMT)
• Preferred: Tennessee licensure as medical technologist as Generalist (MTGN/SP-TN) or specialized in assigned laboratory section. Eligibility requirements will be in compliance with Current State of Tennessee, Division of Health-Related Board

Compensation

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