The School of Medicine has recently completed construction on a new GMP Good Manufacturing Practice) Facility). Our facility is a production facility for the manufacturing of cellular and gene therapy products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control laboratory and quality assurance department, to control collection, processing, storage, and release of cell therapy products. At UCI, the GMP facility will enable clinical trials of cell and gene therapeutics, including viral vector productions, 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 GMP Director, the Biologic Process Development Scientist will support the AAV protein, and antibody Process Development. Design, optimize and scale up biologic manufacturing processes. This role combines hands-on laboratory work with data analysis and tech transfer. Assist in bringing gene therapies from bench to clinical production. Additionally, the Biologic Process Development Scientist will review, revise, and develop standard operating procedures (SOPs) as needed. Maintain up-to-date knowledge of regulatory requirements, lab technologies, and attend relevant training and conferences. Maintain complete documentation as required by Federal law (21CFR 210 and 211) and adhere to Standard Operating Procedures (SOPs). Adhere to maintenance schedules and schedules preventive maintenance, troubleshoot malfunctions and report problems, repairs critical parts of equipment (such as media and fluid pumps, centrifuge, autoclave issues, etc.) designated for certain manufacturing processes and resolve unscheduled maintenance problems. Ensure that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced. Ensure that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs. Ensure the work areas are kept clean, neat and orderly as needed for GMP compliance and supply inventory is maintained at appropriate levels. 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. - Demonstrated knowledge university, state, and federal policies that influence higher education. - Familiarity with regulatory affairs, quality control and production - Experience in writing SOPs and Batch Record - Quality Control Assays Experience (e.g., qPCR, Flow Cytometry, Elisa, etc.). - Development, optimization, and validation of analytical assays - Development, optimization, and validation of analytical assays. - Master's or PhD in molecular biology, microbiology, biochemistry, or related science/engineering field. - Prior experience working in an aseptic environment, biosafety cabinet and working with human tissues required. - 2+ years Flow Cytometry (staining, acquisition, and analysis). - 2+ years of aseptic cell culture (human primary cells and/or human cell lines) - 1-year General knowledge of GMP and GLP procedures Preferred: - Demonstrated experience supervising staff and students in an academic or research setting. - Demonstrated knowledge of program development as well as grant proposal development and administration. - Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution. - Knowledge of human resources management practices and policies. - Knowledge of financial principles and budget practices. - Environmental Monitoring Testing - Experience with maintenance of analytical and retain sample inventory logs under GMP compliance. - Experience in stability testing and environmental monitoring. - 2 years of experience working in GMP facility or industrial scientific setting. Special Conditions: - Is required to lift up to 20lbs - Must be able to work safely with chemicals and hazardous materials - Must be able to work overtime and flexible shifts - Must be able to perform daily facility operation Total Rewards In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits. Consideration for Work Authorization Sponsorship Must be able to provide proof of work authorization