cGMP Cell & Gene Therapy Specialist

UCI School Of Medicine CGMP Facility Role

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the cGMP facility will enable clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility includes a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory.

Your Role on the Team Reporting to the cGMP MSAT Manager, the candidate serves as the critical technical bridge between bench-top innovation, process development, analytical development, and clinical-scale production. In this role, the candidate will provide advanced technical oversight to ensure the seamless transfer, validation, and optimization of both manufacturing processes and analytical methodologies, including but not limit to large-scale productions of 2040L. The ideal candidate will lead process scale-up initiatives, integrate robust analytical assays for process monitoring, evaluate production data for consistency, spearhead root-cause investigations for complex manufacturing deviations, and implement continuous improvement strategies to enhance product yield and operational efficiency. Additionally, the candidate will be responsible for leading and mentoring junior specialists to ensure the flawless execution of all daily production and testing activities.

To be successful, candidates must have a strong background in nonclinical/preclinical development for cell and gene therapies, alongside a proven ability to advance novel therapeutic approaches into clinical development. Exceptional expertise in aseptic behaviors and techniques is mandatory, as is a comprehensive understanding of analytical development frameworks and regulatory/workflow requirements within ISO 5, ISO 7, and ISO 8 cleanroom environments. This position requires hands-on experience creating, writing, and reviewing Standard Operating Procedures (SOPs), Batch Records, and technical protocols or regulatory filings to maintain strict compliance with global cGMP guidelines. Strong problem-solving skills, rigorous attention to detail, and a collaborative mindset are essential for success in this high-impact, cross-functional role.

What It Takes to be Successful Required: Academic background and experience in relevant area of research. Ability to build relationships, collaborate and problem solve both internally and with external organizations. Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders. 3+ years of aseptic cell culture (human primary cells and/or human cell lines) is required General knowledge of GMP and GLP procedures Experience in writing SOPs Experience with Process Development B.Sc. in science, biochemistry or equivalent. B.Sc. degree with more than 3 years of relevant experience. 2 years of experience working in GMP facility preferred Preferred: Demonstrated experience supervising staff and students in an academic or research setting. Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution. Experience with bioreactors; AAV and TFF Familiarity with regulatory affairs, quality control and production Special Conditions: Is required to lift up to 20lbs Frequent walking; Some reaching, stooping, bending, kneeling, crouching Tasks require focused attention to details Must be able to work safely with chemicals and hazardous materials Must be able to work overtime and flexible shifts