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Scientist / Senior Scientist - Cell Bioassay / Potency
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Full-time
- Position/Job Summary: The Scientist/ Sr. Scientist will be a leading member in the Analytical Technologies group responsible for bioassay development, validation, transfer, and execution at Gritstone Bio. The bioassays include cell-based potency assay, ELISA, PCR-based assays, and virus infectivity assays, etc., that are used to support product characterization, release, stability study in GMP setting as well as other research projects for process, formulation, and manufacturing development.
- Excellent training and background in biological sciences, such as cell biology, molecular biology, biochemistry, immunology, virology, etc., is required.
- Perform method development, validation, tech transfer, product characterization, impurity profiling, routine, and stability testing across varieties of biological products.
- Prepare and review notebooks in compliance with Frontage CMC SOPs. Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting.
- Author method SOPs, development reports, qualification/validation reports to support method transfer to GMP QC Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release and stability testing of drug substance and drug products.
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