Biologic Process Development Scientist

Biologic Process Development Scientist

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 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 (21

CFR 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…