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QUALITY CONTROL MICROBIOLOGY MANAGER - 10031399
Duarte, CACity of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
The Quality Control (QC) team for Center for Bioinnovation and Manufacturing is looking for a talented Quality Control Microbiology Manager for overseeing environmental monitoring program of GMP cleanrooms, oversight of microbiological compendial method verification, along with the contamination control program for GMP Manufacturing of cell and gene products. This is a fast-paced lab involved in cutting edge technology, research and clinical cell and gene therapy programs.
You will manage QC staff to include mentoring and training junior team members on testing techniques and procedures. You will be responsible for trending and reporting of site environmental monitoring data as well as the evaluation and potential implementation of rapid micro assays. You will also provide validation support for microbiological assays and equipment along with generating SOPs, and reviewing and approval of test results products manufactured in CBM
As a successful candidate, you will:
· Perform quality control microbiology activities for products to ensure compliance with Good Manufacturing Practices (GMP) for the Center for Bioinnovation and Manufacturing.
· Interpret and evaluate test results, making recommendations for improvements as necessary.
· Oversee QC microbiology staff, scheduling and organizing departmental responsibilities.
· Review and revise standard operating procedures as necessary. Assist in the development and preparation of new standard operating procedures as directed by the Director of QC.
· Share responsibility with the QA Officer for preparedness for inspections by regulatory agencies so that there is a positive outcome and a minimum disruption in the daily operation and ensure that agency inspectors are provided with all necessary information.
· Have meticulous attention to detail and accuracy in lab work and documentation, strictly following established SOPS, as well as accurate record keeping and lab documentation.
Your qualifications should include:
· Bachelor’s Degree with coursework in biology and/or chemistry
· Five years of quality control/research microbiology experience of GMP products plus 1-2 years of experience in a supervisory/managerial capacity. Biotechnology or pharmaceutical industry experience is preferred.
· Master’s or PhD. Degree with coursework in biology and/or chemistry is preferred
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
City of Hope is an equal opportunity employer.
To learn more about our Comprehensive Benefits, please CLICK HERE.