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University of California - Irvine

Quality Control Lead Scientist

University of California - Irvine, Irvine, California, United States, 92713


Who We Are

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.

The School of Medicine has recently completed construction on a new GMP Good Manufacturing Practice Facility. Our facility is a production facility for the manufacturing of cellular and gene therapy products, including a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory.

Your Role on the Team

Reporting to the GMP Manager, the QC lead scientist will oversee the analytical development and quality control (QC) activities to ensure GMP compliance for UCI GMP facility products. Responsibilities include:Establishing and performing in-house assays for product release.Leading and performing a variety of QC functions in support of the GMP facility.Conducting cellular, micro, and molecular biology procedures including Western blot, PCR, Flow cytometry, and gene expression analysis.Performing statistical analysis to generate trend reports on environmental monitoring and product release data.Recruiting, managing, and training QC staff.Maintaining up-to-date knowledge of regulatory requirements and laboratory technologies.Preparing and properly storing all incoming, intermediate, and final products.Ensuring compliance with biohazardous waste handling and laboratory cleanliness.

What It Takes to be Successful

Required:Master's or PhD in molecular biology, microbiology, biochemistry, or a related field.2+ years of aseptic cell culture experience.1-year general knowledge of GMP and GLP procedures.Quality Control Assays Experience (e.g., qPCR, Flow Cytometry).Ability to communicate effectively with diverse stakeholders.Preferred:Experience supervising staff in an academic or research setting.Knowledge of financial principles and budget practices.Special Conditions:Must be able to work safely with chemicals and hazardous materials.Must be able to work overtime and flexible shifts.Conditions of Employment:Background Check and Live ScanLegal Right to work in the United StatesClosing Statement:The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

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