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Senior Scientist, Analytical Development
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Full-time
- 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.
- The candidate will take a leading role in development, qualification, and validation of molecular separation assays for testing vaccine products.
- Good understanding of FDA and ICH guidelines and practical knowledge with assay validation and cGMP is a plus for this position.
- Strong assay development skills.
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements
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