Senior Scientist, Analytical Chemistry

Job Responsibilities:
Generation and/or review of analytical methods and stability study protocols and reports
Troubleshooting issues related to analytical methods/data
Management of analytical chemistry activities at third-party CMOs
Management of synthesis and characterization of reference standards for APIs and impurities
Preparation of analytical chemistry and stability related CMC sections of INDs, IMPDs and NDAs
Trending of stability data for shelf-life prediction, Analytical comparability protocol and execution
Design and development of new assays, including peptide mapping and other advanced analytical methods.
Separation and characterization of protein drug candidates.
Ensuring all analytical activities are conducted in compliance with cGMP, safety, and regulatory requirements. Job Requirements: Ph.D. in analytical chemistry with 2-4 years of experience or M.S. in analytical chemistry with 7- 10 years of experience
Thorough knowledge and understan...