Senior Scientist, Analytical Chemistry

Role: Analytical chemist specializing in biopharmaceuticals, focusing on the development, review, and troubleshooting of analytical methods for small molecules and biologics, including proteins and sterile products. Responsibilities: manage analytical chemistry activities at CMOs, develop assays such as peptide mapping, characterize protein candidates, prepare CMC sections for regulatory submissions (INDs, IMPDs, NDAs), and trend stability data for shelf-life and comparability. Requirements: Ph.D. in analytical chemistry with 2-4 years or M.S. with 7-10 years of relevant experience; expertise in analytical methodologies for small molecules and biologics; familiarity with ICH, FDA, USP guidance; strong communication skills; ability to work independently and manage multiple projects. HighValue: biopharma, biologics, proteins, sterile products, cGMP compliance, regulatory documentation, stability data analysis. WorkSetup: not specified.