Description
The Senior Scientist, Analytical Development role within an Applied Research department develops, validates, transfers, and oversees analytical methods for small- and large-molecule drug substances and products from early clinical development through commercialization. The position leads analytical activities across internal teams and CROs/CMOs, manages stability studies and trend analyses, interprets release and stability data, troubleshoots technical issues, supports QC methods and specifications, prepares technical and regulatory documentation for INDs and NDAs, and serves as the analytical lead on CMC project teams. The role requires extensive pharmaceutical analytical development experience, expertise in chromatographic and common analytical techniques, regulated-environment knowledge, project management, and an advanced degree in analytical or pharmaceutical sciences.
