Manager-TCT/GMP Production Operations

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 is a Seventh-day Adventist, faith and values based Christian institution. Candidates must understand and embrace the mission, purpose, and identity of Loma Linda and its affiliated entities.

We are an equal opportunity employer committed to the principles of diversity. We provide equal opportunities in all aspects of the employment process to every individual, regardless of gender, race, color, age, national origin, ancestry, physical or mental disability, marital or veteran status, genetic information or any other characteristic protected by law. In addition, we will provide reasonable accommodations for otherwise qualified individuals requesting an accommodation due to a disability. If you need accommodation assistance with accessing our job listings or completing an application, or during any other phase of employment with us, please contact Human Resources Management at View phone number on aiapply.co.

Loma Linda University Medical Center is a religiously-qualified Equal Opportunity Employer under Title VII of Civil Rights Act of 1964. No question on this application is asked for the purpose of unlawfully limiting or excluding any applicant’s consideration for employment because of race, color, religion, gender, age, national origin, disability, genetic information, or any other status protected by applicable law. If you need a reasonable accommodation in the hiring process, please notify Human Resource Management.

We appreciate your interest in Loma Linda and wish you success in your job search!