Senior Scientist I, Analytical Development

Role: Senior Scientist I in Analytical Development within biopharmaceutical CMC manufacturing, supporting drug substance and drug product development through analytical method development, validation, and testing. Responsibilities: lead analytical activities for process development, impurity profiling, GLP toxicology, and cGMP clinical materials; design and optimize analytical methods; mentor junior scientists; interpret complex data; ensure compliance with regulatory standards; coordinate analytical projects and communicate results. Requirements: Ph.D. in Chemistry or related field with 2+ years, or equivalent experience with B.S./M.S.; expertise in analytical techniques such as HPLC, LC/MS, GC, FTIR, UV/Vis, and KF; strong knowledge of cGMP, ICH, FDA guidelines; proven experience in pharmaceutical analytical development supporting drug substance and drug product stages. Preferred: leadership in analytical project management, cross-functional collaboration, mentoring, and experience across multiple development phases. HighValue: focus on pharmaceutical analytical development supporting drug substances and products, regulatory compliance, and cross-team coordination. WorkSetup: not specified, but involves laboratory leadership and collaboration.