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At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.
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The FHCRC Quality Control/Analytical Development laboratory performs in-process and release testing assays for T-cell and stem cell therapeutic products manufactured in the GMP Cell Processing Facility. The group also develops and transfers new analytical methods used to characterize the products, and support process development and product comparability. In addition, the group qualifies test methods and equipment to support these activities and actively supports regulatory submissions.
We are searching for a dynamic, skilled, and detail-oriented candidate to join our growing team and initially focus on the performance of flow cytometry based analytical methods.
The Quality Control/Analytical position will primarily focus on the development and performance of flow cytometry based methods in a GMP laboratory environment. Additional responsibilities include development and/or transfer of analytical methods from internal/external partners, generation of laboratory quality systems and standard operating procedures, and maintenance of the lab in state of regulatory compliance. The position may also be required to perform microbiological assays such as endotoxin, gram stain and mycoplasma testing. Future responsibilities will include performance of cell based bioassays and ELISA-based methods to support manufacturing and process development activities.
- BS/MS in a biological science with 5+ years (2+ years MS) with a background in biologics and/or cellular therapeutics.
- Extensive hands-on experience in the performance of flow cytometry methods to characterize stem cells (e.g. using a Guava, Canto, LSR, etc.).
- Familiarity with data analysis/statistical software packages (e.g. FlowJo, JMP, etc.).
- Strong communication and writing skills with demonstrated ability to work in a dynamic team environment.
- Performance of cell culture based functional assays (e.g. target cell killing, cytokine release, q/RT-PCR, ELISA, etc.) and/or microbial methods.
- Experience in the transfer, qualification and validation of analytical methods and equipment under FDA/ICH guidelines.
- Experience generating documents intended for use in a GxP environment or regulatory filings.
- Prior hands-on work in a GxP laboratory environment.
To apply for this position, please CLICK HERE