cGMP QC Specialist

University of California, Irvine•Irvine, CA

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 Manufacturing lead scientist, the candidate will assist in executing the translational development strategy, along with supporting the project development and quality control testing for multiple projects in the GMP Facility. 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. Specific duties include assisting in manufacturing of GMP grade cell lines for gene therapy vector production, in manufacturing, purifying, and characterizing gene therapy vectors (ex. lenti, retro, AAV), in manufacturing GMP grade human multipotent stem cells (ex. MSCs and HSCs) and GMP grade hESC and iPSCs, in performing analyses for identity and functionality on GMP grade iPSCs, hESCs and differentiated tissues using immunofluorescent stains, PCR, and other laboratory tests. Additionally, the candidate will support the process and analytical development, validation, and qualifications tasks associated with any cGMP project. Assists in performing project related techniques in accordance to established standard operating procedures (SOP) with accurate documentation and assists cross functional teams with required activities. May contribute to writing or aiding in the writing of SOPs for the project. Performs routine laboratory tasks and procedures, including but not limited to equipment, routine maintenance and environmental monitoring. Specific duties for laboratory maintenance and documentation include maintaining complete documentation as required by Federal law (21CFR 210 and 211), following Standard Operating Procedures (SOPs) and adhering to Good Documentation Practices, assisting in the preparation and proper storage all incoming, intermediate and final products, assisting with all product manufacturing duties in the GMP facility, applying appropriate labels to incoming and outgoing products and monitoring for proper product labels and handling during manufacturing, maintaining complete documentation throughout the manufacturing process, reporting problems, ensuring that biohazardous and other laboratory waste is handled/emptied appropriately, and that medical waste stream rules and regulations are enforced, and ensuring that work areas and equipment are decontaminated and disinfected observing proper changeover procedures per SOPs. Candidates must be strong team players who thrive in a fast-paced environment. They should be capable of prioritizing tasks effectively while supporting multiple projects simultaneously. Ideal candidates should demonstrate solid technical proficiency, along with strong analytical skills, attention to detail and adherence to established quality standards and regulatory requirements. They should be able to perform accurate testing and documentation and identify and troubleshoot routine issues with supervision. Candidates are expected to support continuous improvement initiatives, collaborate effectively with cross-functional teams, and maintain a safe, compliant, and organized laboratory environment.

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.
Demonstrated knowledge university, state, and federal policies that influence higher education.
2+ 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
B.Sc. in a related field or the equivalent combination of education and relevant experience.
Is required to lift up to 20lbs
Must be able to work safely with chemicals and hazardous materials
Must be able to work overtime and flexible shifts
Must be able to provide proof of work authorization

Nice To Haves

Demonstrated experience supervising staff and students in an academic or research setting.
Experience with bioreactors; AAV and TFF
Familiarity with regulatory affairs, quality control and production
Experience in biological and analytical techniques, including microbiology, cellular biology, molecular biology, and related assays (e.g., Grma Staining, qPCR, flow cytometry, ELISA, spectrophotometry, mammalian cell culture).
1 year of experience working in GMP facility preferred

Responsibilities

assisting in manufacturing of GMP grade cell lines for gene therapy vector production
manufacturing, purifying, and characterizing gene therapy vectors (ex. lenti, retro, AAV)
manufacturing GMP grade human multipotent stem cells (ex. 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
support the process and analytical development, validation, and qualifications tasks associated with any cGMP project
performing project related techniques in accordance to established standard operating procedures (SOP) with accurate documentation
assists cross functional teams with required activities
contribute to writing or aiding in the writing of SOPs for the project
performs routine laboratory tasks and procedures, including but not limited to equipment, routine maintenance and environmental monitoring
maintaining complete documentation as required by Federal law (21CFR 210 and 211)
following Standard Operating Procedures (SOPs) and adhering to Good Documentation Practices
assisting in the preparation and proper storage all incoming, intermediate and final products
assisting with all product manufacturing duties in the GMP facility
applying appropriate labels to incoming and outgoing products and monitoring for proper product labels and handling during manufacturing
maintaining complete documentation throughout the manufacturing process
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