Key Responsibilities: Lead and manage a team of 10+ scientists (Ph.D. and M.Sc.) ensuring scientific excellence and operational efficiency. Extensive knowledge and application of Extractable and Leachable (E&L) testing in compliance with USP monographs and ISO guidelines for medical devices. Oversee operation and maintenance of multiple analytical instruments including LC-MS/MS, GC-MS/MS, ICP-MS, and Ion Chromatography. Lead method development and validation on LC-MS/MS, GC-MS/MS, and ICP-MS platforms. Prepare, review, and implement Standard Operating Procedures (SOPs) related to E&L, laboratory processes, and best practices. Ensure compliance with 21 CFR Part 11, data integrity principles, and good documentation practices within a cGMP laboratory environment. Monitor and manage daily laboratory operations, workflow, and resource allocation. Review and approve SOPs, Certificates of Analysis (COA), and other quality documentation. Utilize analytical techniques (NMR, IR, HPLC, GC, LC-MS)...