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security mass spectrometry hplc cgmp empowerπ Description
- Conduct release testing for nonclinical/clinical viral vector products per GxP.
- Generate, analyze, and interpret analytical data for Drug Substance and finished products.
- Provide SME support for analytical methods in the lab, focusing on SEC.
- Develop, optimize, and revise SOPs; assist in writing SOPs.
- Carry out release, stability, and in-process testing of materials and final products.
- Qualification/validation studies; generate protocols, coordinate experiments, draft reports.
π― Requirements
- Bachelor's degree in chemistry or biochemistry with 3-5 years HPLC experience.
- Proficient in HPLC calibration/operation with Empower; PA800 and Mass Spectrometry.
- Lab experience with SEC, CE-SDS, and DLS.
- Quality control background; solid molecular biology foundation.
- Experience with viral vectors (AAV) is a plus; knowledge of cGMPs/regulatory prerequisites.
- Familiarity with statistical methods for data analysis.
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