cGMP Cell & Gene Therapy Specialist

University of California, Irvine•Irvine, CA

1d•Onsite

About The Position

The University of California, Irvine (UCI) School of Medicine 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, the 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.
General knowledge of GMP and GLP procedures
Experience in writing SOPs
B.Sc. degree with more than 3 years of relevant experience.
3+ years of aseptic cell culture (human primary cells and/or human cell lines) is required.
Must be able to provide proof of work authorization.

Nice To Haves

Background in nonclinical development for gene and/or cell therapies.
Proven ability to advance novel therapeutic approaches into clinical development.
Experience in creating, writing, and reviewing Standard Operating Procedures (SOPs) and Batch Records is highly preferred.
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
Experience with Process Development
2 years of experience working in GMP facility

Responsibilities

Play a key scientific role in bridging the gap between bench-top innovation and clinical-scale production with duties spanning across process development and GMP manufacturing.
Work in an independent fashion with minimum daily supervision on the manufacturing of biological products.
Demonstrate strong knowledge of aseptic behaviors and techniques, as well as a solid understanding of regulations and workflow requirements within ISO 5, ISO 7, and ISO 8 cleanroom environments.
Lead junior specialists and ensure successful execution of production activities including large scale production (20-40L scales).
Design robust processes for autologous and allogeneic therapies while providing hands-on technical leadership within state-of-the-art cleanroom facilities.
Manufacture GMP grade formulations, store them under GMP conditions, and prepare final formulations for patient administration.
Review test results according to laboratory policy and procedure, and verify results, monitoring for completeness, accuracy, clinical validity, legibility, documentation, and transcription errors.
Maintain complete documentation as required by Federal law (21CFR 210 and 211).
Adhere to Standard Operating Procedures (SOPs).
Prepare and properly store all incoming, intermediate, and final products.
Perform all product manufacturing duties in the GMP facility while fully gowned.
Apply appropriate labels to incoming and outgoing products and monitor for proper product labels and handling during manufacturing.
Maintain complete documentation throughout the manufacturing process.
Adhere to maintenance schedules and schedule preventive maintenance.
Troubleshoot malfunctions and report problems.
Ensure that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced.
Ensure that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs.
Ensure supply inventory is maintained at appropriate levels.