Job Summary: The Manager-TCT/GMP Production Operations manages the production and storage of products made in the TCT/GMP Laboratory. The Production manager will oversee the day-to-day activities of the TCT/GMP Production team and establish appropriate procedures, training programs, and optimal workflows to produce high-quality cell therapeutic products for patients. This position will provide leadership, technical expertise, and hands-on support for the validation and execution of the production process, as well as managing deviations, CAPAs, and change control processes. This role will be critical in managing production resources and timelines, interfacing with supply chain and logistics teams to ensure timely delivery of materials for production, engaging and coordinating with cross-functional teams to assure the quality of work are complete, accurate, and in accordance with regulatory standards. Reports to the Director-TCT/GMP Laboratory Operations. Performs other duties as needed.
Education and Experience: Bachelor’s Degree in the life sciences, physical sciences, engineering, or related discipline required. Master’s Degree preferred. Five years of experience in a cGMP environment required, preferably within cell and gene therapy manufacturing in industry or academic institutions. Two years of supervisory experience required.
Knowledge and Skills: Proven leadership skills and the ability to take on increasing responsibility in complex environments. Strong knowledge of cell-based therapies, including CAR-T, gene therapy, and stem cell technologies. Advanced knowledge of aseptic techniques, manufacturing processes and technologies for cell & gene therapy products. Ability to operate in a regulated environment, with In-depth understanding of FDA regulatory requirements, cGMP guidelines and quality standards. Familiarity with proper operation and maintenance of basic and complex laboratory equipment, including centrifuges, biosafety cabinets, LN2 freezers and controlled rate freezers. 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; work well under pressure; problem solve; organize and prioritize workload; recall information with accuracy; pay close attention to detail. Able to distinguish colors and smells as necessary for patient care; hear sufficiently for general conversation in person and on the telephone; identify and distinguish various sounds associated with the workplace/patient care; see adequately to read computer screens, medical records, and written documents necessary to position; discern temperature variances through touch.
Licensures and Certifications: California Clinical Laboratory Scientist (CLS) License preferred.
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.
Loma Linda University Health’s story is one of hope. Our people strongly believe in the work of physical, mental, and spiritual healing. They are also committed to excellence, integrity, and teamwork. We are a faith-based academic medical center in Southern California’s Inland Empire, and since our establishment in 1905, we’ve been a local, regional, national, and international leader in education, clinical care, and research.
Our 18,000 talented healthcare team members work in our system’s six hospitals, providing whole-person, patient-focused care to more than 57,000 inpatients and over a million outpatients annually. Our passion is to bring hope to each patient and family who seeks our help during their most vulnerable moments in life.
U.S. News and World Report ranks Loma Linda University Medical Center as a Top Riverside/San Bernardino metro area hospital. LLU Children’s Hospital and LLU Medical Center — Murrieta are on the U.S. News list of Top Performing Hospitals for Maternity Care and the Newsweek list of Best Maternity Care Hospitals. Our Medical Center and Children’s Hospital nursing teams have also achieved the prestigious Magnet Status recognizing our strong commitment to nursing excellence.
Loma Linda University’s eight professional schools offer more than 100 academic programs designed to prepare thousands of skilled Christian healthcare workers for service in our local area and locations worldwide. Our graduates enter their careers with an intellectual curiosity and a strong foundation of the knowledge and skills needed for their chosen field. The Great Colleges to Work For program has named Loma Linda University as an outstanding place to work six of the last seven years, and has added the University to its Honor Roll of institutions three times.
