Biologic Process Development Scientist, GMP Cell Therapy

University of California, Irvine; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Sick and vacation time

Retirement savings plans

Discounts and perks

Job summary

University of California, Irvine (UCI) is seeking a Biologic Process Development Scientist to design, optimize, and scale up manufacturing processes for gene therapies. You will perform hands-on lab work and data analysis, supporting transfer to clinical production in a GMP environment.

Reporting to the GMP Director, you will review SOPs, ensure regulatory compliance, and maintain complete documentation. The role requires aseptic technique and experience with QC assays and analytical methods.

Qualifications

• Required: advanced knowledge in regulatory affairs, quality control and production.
• Experience writing SOPs and Batch Records.
• 2+ years Flow Cytometry and 2+ years aseptic cell culture.
• 1-year GMP/GLP procedures knowledge.
• Master’s or PhD in related science/engineering field.

Responsibilities

• Design, optimize and scale up biologic manufacturing processes.
• Assist in bringing gene therapies from bench to clinical production.
• Review, revise and develop SOPs as needed.
• Maintain documentation per 21 CFR 210/211 and SOPs.
• Troubleshoot equipment and maintain GMP compliance.

Skills

Flow Cytometry

Aseptic Cell Culture

GMP/GLP Knowledge

SOP Writing

Batch Records

Data Analysis

Regulatory Compliance

Education

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

Job description

University of California, Irvine (UCI) is seeking a Biologic Process Development Scientist to design, optimize, and scale up manufacturing processes for gene therapies. You will perform hands-on lab work and data analysis, supporting transfer to clinical production in a GMP environment.

Reporting to the GMP Director, you will review SOPs, ensure regulatory compliance, and maintain complete documentation. The role requires aseptic technique and experience with QC assays and analytical methods.