Biologic Process Development Scientist - Cell Therapy GMP

UC Irvine; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

UC Irvine is seeking a Biologic Process Development Scientist to design, optimize, and scale up biologic manufacturing processes, including AAV protein and antibody development. The role blends hands-on lab work with data analysis and tech transfer, supporting gene therapies from bench to clinical production.

The candidate will review SOPs, stay current with regulatory requirements, and maintain thorough documentation in line with 21 CFR 210/211.

Qualifications

• Academic background in a relevant field.
• Strong written and verbal communication skills.
• Familiarity with regulatory affairs, quality control and production.
• Experience writing SOPs and Batch Records.
• Experience with QC assays (qPCR, Flow Cytometry, ELISA).
• Development, optimization, and validation of analytical assays.

Responsibilities

• Design, optimize and scale up biologic manufacturing processes.
• Assist in tech transfer from bench to clinical production.
• Review, revise and develop SOPs as needed.
• Maintain knowledge of regulatory requirements and lab technologies.
• Ensure GMP/GLP compliance and proper documentation.

Education

Master’s or PhD in molecular biology, microbiology, biochemistry, or related science/engineering field

Job description

UC Irvine is seeking a Biologic Process Development Scientist to design, optimize, and scale up biologic manufacturing processes, including AAV protein and antibody development. The role blends hands-on lab work with data analysis and tech transfer, supporting gene therapies from bench to clinical production.

The candidate will review SOPs, stay current with regulatory requirements, and maintain thorough documentation in line with 21 CFR 210/211.