Principal Scientist, Small Molecule Analytical Chemistry

Role: Principal Scientist leading analytical characterization in drug product development and commercialization within a biopharma setting. Responsibilities: oversee analytical method development/validation, drug product testing, stability studies, process characterization, and support scale-up/validation; prepare regulatory CMC documentation and respond to inquiries; collaborate with cross-functional teams; mentor scientists and develop organizational capabilities. Requirements: PhD in Analytical Chemistry or related, 7+ years (PhD) or 10+ years (MS) pharma experience; extensive hands-on expertise with HPLC, UHPLC, GC, spectroscopy, and validation; proven regulatory documentation experience (IND, NDA, etc.); strong problem-solving, communication, and team leadership skills. Preferred: experience with hyphenated techniques like LC/MS and troubleshooting. High-Value: small molecule pharma, late-stage development, cGMP environment, global regulatory submissions, cross-site collaboration, 10% travel. Location: Rahway, NJ and West Point, PA sites.