The Fred Hutchinson Cancer Research Center (FHCRC), home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's five scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Hutchinson Center, in collaboration with its clinical and research partners, the Seattle Cancer Care Alliance, University of Washington, and Seattle Children's, is the only National Cancer Institute (NCI)-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference.
The Analytical Development and Quality Control group performs receipt, in-process and final release testing assays for T-cell and stem cell therapeutic products manufactured in the cGMP Cell Processing Facility. The group will also develop new analytical methods used to characterize the products and support process development, product comparability and stability studies. In addition the group will also qualify test methods and equipment in support of GMP regulatory requirements.
A senior research technician position is immediately available in the Analytical Development and Quality Control Group. The position will primarily focus on routine environmental monitoring and microbiology testing in support of manufacturing and process development activities. This will including completing GMP documentation, following SOPs, and maintaining the lab in state of regulatory compliance. The position will manage contract labs to which QC samples may be outsourced. The position will also perform method development including generating SOPs, assay qualification, and the generation of QA approved test methods.
Ideal qualifications include:
- 5+ years experience in microbiology methods used in QC release testing and characterization of immune cells and/or stem cells.
- Experience with the development of analytical methods that include: rapid sterility and mycoplasma testing, Gram stain, endotoxin, viral testing, microbial identification
- Experience with environmental monitoring, sample tracking/handling, and managing the outsourcing of sample testing to contract labs
- Experience with the qualification and validation of analytical methods and equipment intended for product release testing and characterization as required under FDA and ICH guidelines
- Excellent communication skills and writing ability; including previous experience generating documents intended for use in a GMP environment or regulatory filings
- Familiarity with data analysis software packages and general statistical concepts and methods.
- Bachelor's degree (or higher) or comparable experience in biological sciences
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