Analytical Development/QC Associate II

Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here.
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 with minimal side effects. 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. Careers Start Here.

The Fred Hutch Analytical Development and Quality Control 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, detail-oriented candidate to join our growing team and help make a difference.

The Analytical Development/Quality Control position primarily focuses on the performance of flow cytometry, cell culture, and ELISA based assays to support manufacturing and process development activities. The position may also perform microbiological assays such as endotoxin, gram stain and mycoplasma testing. Additional responsibilities include development and/or transfer of analytical methods from internal/external sources, generation of laboratory quality systems and standard operating procedures, participation in laboratory investigations, and maintenance of the lab in state of regulatory compliance.

- BS/MS in biological science with 5+ years (2+ years w/ MS) experience in the performance of analytical methods used in QC release and characterization testing of immune cells and/or stem cells; preferably in a GxP environment.
- Background in biologics and/or cellular therapeutics highly desirable
- Hands on experience with flow cytometry, cell culture based functional assays (e.g. target cell killing, cytokine release, q/RT-PCR, ELISA, etc.) and/or microbial methods.
- Experience preferred but not required in the transfer, qualification and validation of analytical methods and equipment under FDA/ICH guidelines.
- Strong communication skills and writing ability. Experience generating documents intended for use in a GxP environment or regulatory filings strongly desired.
- Familiarity with data analysis/statistical software packages (e.g. FlowJo, Gen5, JMP, etc) desirable, but not required.

To apply for this position, please CLICK HERE

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