Manufacturing Specialist

University of California, Irvine•Irvine, CA

1d•Onsite

About The Position

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. To learn more about UC Irvine, visit www.uci.edu. The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the cGMP facility will enable clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility includes a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory. Reporting to the cGMP lead scientist, the candidate will play a key scientific role in executing the translational development strategy for the cGMP. A background in nonclinical development for gene and/or cell therapies and a proven ability to advance novel therapeutic approaches into clinical development is highly desirable. Ability to work in an independent fashion with minimum daily supervision on the manufacturing of biological products is necessary. Candidates must 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. The ideal candidate will be capable of leading junior specialists and ensuring successful execution of production activities including large scale production (20-40L scales). Experience in creating, writing, and reviewing Standard Operating Procedures (SOPs) and Batch Records is highly preferred. Successful candidates will exhibit excellent problem-solving skills, a high level of attention to detail, and a collaborative mindset that supports effective teamwork. Specific duties for cell and gene manufacturing include manufacturing GMP grade cell lines for gene therapy vector production, manufacturing, purifying, and characterizing gene therapy vectors (lenti, retro, AAV), manufacturing GMP grade human multipotent stem cells (MSCs and HSCs) and GMP grade hESC and iPSCs, performing analyses for identity and functionality on GMP grade iPSCs, hESCs and differentiated tissues using immunofluorescent stains, PCR, and other laboratory tests. Additionally, manufacturing GMP grade formulations, storing them under GMP conditions and preparing final formulations for patient administration, reviewing test results according to laboratory policy and procedure, and verifying results, monitoring for completeness, accuracy, clinical validity, legibility, documentation, and transcription errors. Specific duties for laboratory maintenance and documentation include maintaining complete documentation as required by Federal law (21CFR 210 and 211), adhering to Standard Operating Procedures (SOPs), preparing and properly storing all incoming, intermediate and final products, performing all product manufacturing duties in the GMP facility while fully gowned, appling appropriate labels to incoming and outgoing products and monitoring for proper product labels and handling during manufacturing, maintaining complete documentation throughout the manufacturing process, adhering to maintenance schedules and scheduling preventive maintenance, troubleshooting malfunctions and reporting problems, ensuring that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced, ensuring that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs, and ensuring supply inventory is maintained at appropriate levels.

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. degree with more than 3 years of relevant experience.

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

manufacturing GMP grade cell lines for gene therapy vector production
manufacturing, purifying, and characterizing gene therapy vectors (lenti, retro, AAV)
manufacturing GMP grade human multipotent stem cells (MSCs and HSCs) and GMP grade hESC and iPSCs
performing analyses for identity and functionality on GMP grade iPSCs, hESCs and differentiated tissues using immunofluorescent stains, PCR, and other laboratory tests
manufacturing GMP grade formulations, storing them under GMP conditions and preparing final formulations for patient administration
reviewing test results according to laboratory policy and procedure, and verifying results, monitoring for completeness, accuracy, clinical validity, legibility, documentation, and transcription errors
maintaining complete documentation as required by Federal law (21CFR 210 and 211)
adhering to Standard Operating Procedures (SOPs)
preparing and properly storing all incoming, intermediate and final products
performing all product manufacturing duties in the GMP facility while fully gowned
appling appropriate labels to incoming and outgoing products and monitoring for proper product labels and handling during manufacturing
maintaining complete documentation throughout the manufacturing process
adhering to maintenance schedules and scheduling preventive maintenance
troubleshooting malfunctions and reporting problems
ensuring that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced
ensuring that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs
ensuring supply inventory is maintained at appropriate levels