St. Jude Children’s Research Hospital was the first pediatric cancer research center in the U.S. to open its own on-site GMP facility, Children’s GMP, LLC. Now St. Jude, a federally-designated Hemophilia Treatment Center and pioneer of the Global Hemophilia Gene Therapy Trial, is working to develop a potential cure for Factor IX deficiency. Through assistance from Hemophilia of Georgia, we are seeking a data-driven and detail-oriented Senior Scientist I of Quality Control.
This position designs biological and analytical methods for the in-process, release, and stability testing of biological products that are developed and produced in Children’s GMP. Responsible for assay development and assay validation. Combines knowledge of cell-based assays, analytical chemistry, molecular biology, and biochemistry to further develop methods behind characterization of the products. Ensures methods meet requirements established by the FDA and ICH guidelines for a fully-validated assay. Generates detailed documents including development reports, validation protocols, and Standard Operating Procedures (SOP). Responsible for training of additional Quality Control personnel.
The ideal candidate possesses great technical writing skills, unmatched attention to detail, and a proven history of recording data and writing reports. Experience and knowledge of assay development is highly preferred.
Bachelor's degree in biochemistry, chemistry or analytical chemistry or related field required.
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