cGMP Cell & Gene Therapy Specialist

University of California, Irvine•Irvine, CA

1d•Onsite

About The Position

The School of Medicine at UC Irvine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). This facility is designed for the manufacturing of pharmaceutical or cellular products, encompassing manufacturing space, a storage warehouse for raw and finished products, and support laboratory areas. It includes quality control and quality assurance programs to manage the collection, processing, storage, and release of cell therapy products. At UCI, this cGMP facility will support clinical trials of cell therapeutics, including stem cell populations, bone marrow transplantation, and Chimeric Antigen Receptor (CAR) T-cells. The facility features a seven-room GMP cellular therapy and viral vector facility with an adjacent quality control laboratory.

Requirements

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.
3+ years of aseptic cell culture (human primary cells and/or human cell lines) is required.
General knowledge of GMP and GLP procedures.
Experience in writing SOPs.
Experience with Process Development.
B.Sc. in science, biochemistry or equivalent.
B.Sc. degree with more than 3 years of relevant experience.
Exceptional expertise in aseptic behaviors and techniques is mandatory.
Comprehensive understanding of analytical development frameworks and regulatory/workflow requirements within ISO 5, ISO 7, and ISO 8 cleanroom environments.
Strong problem-solving skills, rigorous attention to detail, and a collaborative mindset are essential.

Nice To Haves

Demonstrated experience supervising staff and students in an academic or research setting.
Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution.
Experience with bioreactors; AAV and TFF.
Familiarity with regulatory affairs, quality control and production.
2 years of experience working in GMP facility preferred.

Responsibilities

Provide advanced technical oversight to ensure the seamless transfer, validation, and optimization of manufacturing processes and analytical methodologies, including large-scale productions of 20–40L.
Lead process scale-up initiatives.
Integrate robust analytical assays for process monitoring.
Evaluate production data for consistency.
Spearhead root-cause investigations for complex manufacturing deviations.
Implement continuous improvement strategies to enhance product yield and operational efficiency.
Lead and mentor junior specialists to ensure the flawless execution of all daily production and testing activities.
Create, write, and review Standard Operating Procedures (SOPs), Batch Records, and technical protocols or regulatory filings to maintain strict compliance with global cGMP guidelines.