GMP Biologic Process Developer - Cell Therapy

University-of-California,-Irvin; Irvine (CA); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Retirement savings plans

Discounts and perks

Job summary

University of California, Irvine is seeking a Biologic Process Development Scientist to support AAV protein and antibody process development in a GMP cellular therapy manufacturing facility. You will design, optimize, and scale biologic manufacturing processes, perform hands‑on lab work, data analysis and tech transfer to clinical production.

Responsibilities include developing SOPs, maintaining regulatory documentation, ensuring GMP/GLP compliance, and collaborating with cross‑disciplinary

Qualifications

• Academic background in relevant research area.
• Ability to build relationships and collaborate with internal and external organizations.
• Advanced oral and written communication skills with diverse stakeholders.
• Familiarity with university, state, and federal policies affecting higher education.
• Knowledge of regulatory affairs, quality control and GMP/GLP procedures.
• Experience writing SOPs and Batch Records.
• Experience with quality control assays (qPCR, Flow Cytometry, ELISA).
• Development, optimization, and validation of analytical assays.
• Master’s or PhD in related science/engineering field.
• Experience in aseptic environment and with human tissues.

Responsibilities

• Design, optimize, and scale biological manufacturing processes for gene therapies.
• Hands-on lab work coupled with data analysis and tech transfer.
• Assist in bringing gene therapies from bench to clinical production.
• Review and develop SOPs and maintain regulatory documentation.
• Maintain compliance with GMP/GLP and related regulatory requirements.

Skills

Academic background

Collaboration

Communication (oral & writing)

Regulatory knowledge

SOPs knowledge

Quality control

Analytical assays

Flow Cytometry

aseptic cell culture

GMP/GLP awareness

Education

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

Tools

qPCR

Flow Cytometry

ELISA

Job description

University of California, Irvine is seeking a Biologic Process Development Scientist to support AAV protein and antibody process development in a GMP cellular therapy manufacturing facility. You will design, optimize, and scale biologic manufacturing processes, perform hands‑on lab work, data analysis and tech transfer to clinical production.

Responsibilities include developing SOPs, maintaining regulatory documentation, ensuring GMP/GLP compliance, and collaborating with cross‑disciplinary