Biologic Process Development Scientist

About Us

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 manufacturing space, a storage warehouse for raw and finished products, and support laboratory areas, including a quality control laboratory and quality assurance department, to control collection, processing, storage, and release of cell therapy products. The GMP facility enables clinical trials of cell and gene therapeutics, including viral vector productions, stem cell populations, bone marrow transplantation, and 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.

About the Role

Reporting to the GMP Director, the Biologic Process Development Scientist will support AAV protein and antibody process development. This role combines hands-on laboratory work with data analysis and tech transfer to design, optimize, and scale up biologic manufacturing processes. You will assist in bringing gene therapies from bench to clinical production, review and develop standard operating procedures (SOPs), and maintain up-to-date knowledge of regulatory requirements and lab technologies.

Responsibilities

• Design, optimize, and scale up biologic manufacturing processes.
• Assist in transitioning gene therapies from research to clinical production.
• Review, revise, and develop standard operating procedures (SOPs) as needed.
• Maintain complete documentation as required by Federal law (21 CFR 210 and 211) and adhere to SOPs.
• Adhere to maintenance schedules, perform preventive maintenance, troubleshoot malfunctions, and report/repair critical equipment (e.g., media and fluid pumps, centrifuge, autoclave).
• Ensure proper handling and disposal of biohazardous and laboratory waste in compliance with regulations.
• Maintain clean, decontaminated, and GMP-compliant work areas and equipment.
• Manage supply inventory to appropriate levels.
• Perform quality control assays (e.g., qPCR, Flow Cytometry, ELISA).
• Develop, optimize, and validate analytical assays.
• Conduct environmental monitoring testing.
• Maintain analytical and retain sample inventory logs under GMP compliance.
• Perform stability testing and environmental monitoring.

Requirements

• Master’s or PhD in molecular biology, microbiology, biochemistry, or a related science/engineering field.
• 2+ years of experience in Flow Cytometry (staining, acquisition, and analysis).
• 2+ years of aseptic cell culture experience (human primary cells and/or human cell lines).
• 1+ year of general knowledge of GMP and GLP procedures.
• Prior experience working in an aseptic environment, biosafety cabinet, and with human tissues.
• Experience in writing SOPs and Batch Records.
• Experience with quality control assays (e.g., qPCR, Flow Cytometry, ELISA).
• Ability to lift up to 20 lbs.
• Ability to work safely with chemicals and hazardous materials.
• Ability to work overtime and flexible shifts.
• Ability to perform daily facility operations.

Preferred Qualifications

• Demonstrated experience supervising staff and students in an academic or research setting.
• Experience with program development, grant proposal development, and administration.
• 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.
• 2+ years of experience working in a GMP facility or industrial scientific setting.

Benefits

In addition to the salary range listed, we offer a wealth of benefits, including:

• Medical insurance
• Sick and vacation time
• Retirement savings plans
• Access to a variety of discounts and perks

Special Conditions of Employment

• Background check and Live Scan required.
• Must comply with UCI’s vaccination policies, smoking and tobacco policy, and drug-free environment requirements.
• Must disclose any prior employment misconduct or ongoing investigations as a condition of employment.
• Must provide proof of legal right to work in the United States.
• Additional conditions may apply, including compliance with the California Child Abuse and Neglect Reporting Act and E-Verify requirements.
• Pre-placement health evaluation may be required.