Director-TCT/GMP Operations

4 weeks ago

Loma Linda, California, United States Loma Linda University Medical Center Full time

UH: Stem Cell Transplant - (Full-Time, Day Shift) -

Our mission is to continue the teaching and healing ministry of Jesus Christ. Our core values are compassion, excellence, humility, integrity, justice, teamwork and wholeness.

The Director-TCT/GMP Operations (Transplant and Cellular Therapy-Good Manufacturing Practices Laboratory) ensures the quality and safety of all products manufactured through the TCT-GMP Lab. The Director of Operations will report directly and administratively to the Assistant Vice President & Executive Director of LLUCC, and indirectly and technically to the Director of the Laboratory. In close collaboration with the Director of the Laboratory, the Director of Operations position is responsible for producing cell therapy products that comply with federal (including FDA), industry, and Foundation for the Accreditation of Cellular Therapy (FACT) standards and regulations. In addition, the position oversees the day-to-day operations of that lab, including non-investigational and investigational products, product pipelines, product development, delivery, product analysis, quality assurance (QA) testing, outcomes monitoring and reporting. The position also supervises the processing, manufacturing, process development, testing, storage, distribution of cell therapy products. The position ensures that cellular therapy products released by the laboratory meet clinical and quality criteria for infusion in the standard of care and clinical trial settings. The position is also responsible for the development and implementation of standard operating procedures (SOPs). The Director of Operations will direct the various departments (TCT, GMP and storage) of the lab to meet operational needs and develop business plans to support the projects of the laboratory. The Director of Operations will maintain and operate the laboratory with current FACT and Good Manufacturing Practice (cGMP) practices as specified by FACT, FDA and similar regulatory and accrediting entities. The Director of Operations, in collaboration with the Director of the Laboratory, will participate in grants and proposal writing as it relates to TCT-GMP lab. The Director of Operations will collaborate daily with clinical team to make critical decisions resulting in the highest quality product that meet the patient's treatment plan as well as with other various users of the facility.

Performs other duties as needed.

Bachelor's degree in a Biological Science or Clinical Laboratory Science required. Master's degree in the life sciences (e.g. Biologics or Pharmaceutical), or PhD, MD (or equivalent) degree in a related scientific discipline preferred. Five years of experience (leadership experience preferred) in a TCT-GMP lab or in a related academic or industrial setting (e.g. cellular, biological manufacturing experience, process development and analytical methods) required.

Knowledge of Hematopoietic Progenitor Cells/Immune Effector Cells, other cellular products and viral production laboratory processing. Understands Good Manufacturing Practices (cGMPs, GLPs, GDPs) and cellular and gene therapies. Knowledge of federal and state regulations, such as FDA and FACT, and theoretical and technical principals related to transplant cell therapy laboratory and GMP process implementation and maintenance. Understanding of cell processing, viral production, immunology, cell biology, hematology and cell products banking. Remain up to date with literature in the field of cellular therapy. Able to pay attention to detail and exhibit analytical skills to perform error free cell processing, meet specific cell therapy product specifications, and ensure data accuracy. Able to: read; write legibly; speak in English with professional quality; use computer and software programs necessary to the position; troubleshoot and calibrate patient care equipment. Able to relate and communicate positively, effectively, and professionally with others; be assertive and consistent in following and/or enforcing policies; work calmly and respond courteously when under pressure; lead, supervise, teach, and collaborate; accept direction. Able to think critically; work independently with minimal supervision; perform basic math functions; manage multiple assignments effectively; problem solve; organize and prioritize workload; recall information with accuracy; pay close attention to detail. Able to distinguish colors and smells as necessary; hear sufficiently for general conversation in person and on the telephone; identify and distinguish various sounds associated with the work place/patient care; see adequately to read computer screens, medical records, and written documents necessary to position; discern temperature variances through touch.

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