Manager-TCT/GMP Production Operations at Loma Linda University Health in Loma Linda, CA, United States

Job description

• 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.

Responsibilities

• Manages the production and storage of products made in the TCT/GMP Laboratory.
• Oversees day-to-day activities of the TCT/GMP Production team.
• Establishes appropriate procedures, training programs, and optimal workflows.
• Provides leadership, technical expertise, and hands-on support for validation and execution of production processes.
• Manages deviations, CAPAs, and change control processes.
• Manages production resources and timelines.
• Interfaces with supply chain and logistics teams.
• Engages and coordinates with cross-functional teams to assure quality.
• Reports to the Director-TCT/GMP Laboratory Operations.
• Performs other duties as needed.

Requirements

• 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.

Skills

Required

• Proven leadership skills

Benefits

• $128.086.40 - $194,937.60 / Annually