Memphis, TN

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There’s a reason St. Jude Children’s Research Hospital is recognized as a great place to work. Because at our world-class pediatric research hospital, every one of our professionals shares our commitment to make a difference in the lives of the children we serve. There’s a unique bond when you’re part of a team that gives their all to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative, positive environment where everyone, regardless of their role, receives the resources, support and encouragement to advance and grow their careers and be the force behind the cures.

Supervisor - Human Applications Lab

St. Jude Children’s Research Hospital, a NCI designated comprehensive care center, is consistently ranked on Fortune Magazine’s “100 Best Places to Work For” list. Because at our world-class pediatric research hospital, every one of our professionals shares our commitment to make a difference in the lives of the children we serve.

The Human Applications (Cellular Therapy) Laboratory (HAL) supports the Department of Bone Marrow Transplantation and Cellular Therapy by providing products for patients enrolled in investigator-initiated clinical research protocols. The laboratory supports many treatment 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 Stem Cell Processing Section providing cellular therapy product processing in accordance with good tissue practices and good manufacturing practices.

In this role, the selected candidate will supervise the Stem 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.

This position will be 100% on-site, Monday – Friday, primarily day shift with flexibility in working schedule to accommodate work when necessary.

Responsibilities:

Schedule the work of the processing staff and monitor workload and staffing in order to maintain productivity within acceptable limits.
Serve as a technical On-Call resource when scheduled.
Review processing records for completion according to good documentation practices.
Review and manage cell therapy product inventories.
Review monitoring data, i.e., temperature graphs, humidity levels, and quality control results for excursions or trends.
Coordinate and manage ship out and receipt of external manufactured clinical trial products.
Train processing staff and perform annual competency assessment.
Perform critical bench work for specialized technical procedures as needed.
Oversight and management of Proficiency Testing surveys.
Maintain, update, and revise the Processing Section SOPs, in collaboration with senior technologists, HAL leadership and the QA Unit as required for new methods and regulatory requirements.
In conjunction with the QA Unit, support development and execution of equipment qualification / process validation plans.
In conjunction with the QA Unit, oversee preventive maintenance and repair of equipment.
Manage and maintain inventory of supplies and reagents to support processing activities.
Participate in deviation reporting, investigation, and corrective action plans.

Skills / Knowledge / Abilities:

Good working knowledge of manual and automated procedures in the stem cell processing laboratory.
Knowledge of FACT standards and applicable FDA regulations for cellular therapy products.
Ability to organize and coordinate multiple complex tasks to achieve accurate high quality work.
Attention to detail with excellent mathematical and communication skills.
Ability to work independently and collaboratively in a team environment.

A minimum of eight (8) years of laboratory experience with five (5) years of experience in hematopoietic stem cell processing required.
Experience in a leadership or supervisory capacity preferred.