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Senior Analyst / Scientist, Quality Control Chemistry
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- The Senior Analyst / Scientist will also support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, routine GMP testing of AAV vector analytical methods ( HPLC, AUC, UV, CE-SDS, compendia methods and other methods as needed ) for lot release and stability.
- The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed.
- The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
- o Lead and support QC deviations, investigations, CAPA, Change control, analytical method performance trending and root cause analysis, as needed.
- o Investigate and evaluate cutting edge biophysical and analytical instrumentation and stay up to date on state-of-the-art methodologies for AAV characterization.
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