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UC Irvine · 3 days ago

cGMP QC Specialist

Irvine, CA

Full-time

Onsite

Entry, Mid Level

2+ years exp

UC Irvine is a prestigious public university known for its academic achievement and research innovation. The cGMP QC Specialist will assist in executing the translational development strategy and support quality control testing for projects in the GMP Facility, focusing on gene and cell therapies.

Higher Education

Diversity & Inclusion

No H1B

Responsibilities

Assist in manufacturing of GMP grade cell lines for gene therapy vector production

Manufacture, purify, and characterize gene therapy vectors (ex. lenti, retro, AAV)

Manufacture GMP grade human multipotent stem cells (ex. MSCs and HSCs) and GMP grade hESC and iPSCs

Perform 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

Assist in performing project related techniques in accordance to established standard operating procedures (SOP) with accurate documentation

Assist cross functional teams with required activities

Contribute to writing or aiding in the writing of SOPs for the project

Perform routine laboratory tasks and procedures, including but not limited to equipment, routine maintenance and environmental monitoring

Maintain complete documentation as required by Federal law (21CFR 210 and 211), following Standard Operating Procedures (SOPs) and adhering to Good Documentation Practices

Assist in the preparation and proper storage all incoming, intermediate and final products

Assist 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

Maintain complete documentation throughout the manufacturing process

Report problems, ensuring 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

Qualification

CGMP knowledgeAseptic cell cultureSOP writingBiological techniquesAnalytical techniquesTeam collaborationProblem solvingCommunication skillsAttention to detail

Required

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

Preferred

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