Senior Scientist, Quality CMC

Role: Senior Scientist, CMC Quality, providing scientific leadership in analytical science to ensure product quality and risk assessment throughout the product lifecycle. Responsibilities: lead complex investigations into OOS, OOT, deviations, and product quality issues; interpret stability trends and analytical data; develop risk assessments, scientific rationales, and regulatory documentation; support IND/NDA/MAA submissions and post-approval commitments; mentor junior scientists and drive quality improvement projects. Requirements: BS in Chemistry, Pharmaceutical Sciences, or related field; minimum of 8 years in pharmaceutical/biotech QC, CMC, or Analytical Sciences; proven experience in root cause analysis, complex investigations, and cross-functional collaboration; strong knowledge of analytical techniques (GC, HPLC, Dissolution), GMP, and global regulatory standards (FDA, EMA, ICH). HighValue: expertise in analytical method capability and variability, stability trend interpretation, and CMC development/support; experience supporting regulatory filings and audits; some travel required. WorkSetup: not specified.