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Sr. Scientist, Analytical Development
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- We are seeking a Sr. Scientist to join our Analytical Development department to lead a group of energetic scientists.
- The qualified individual should have demonstrated proficiency with development and application of HPLC, LC/MS and/or Size Separation based methods for phase-appropriate characterization of protein or vaccine products, including but not limited to peptide mapping, size-exclusion chromatography (SEC), residual assays, and intact mass determination via high-resolution LC/MS analysis.
- Good understanding of FDA and ICH guidelines and practical knowledge with assay validation and cGMP is a plus for this position.
- Write, edit, and review analytical sections of CMC regulatory filings
- Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology
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