Manager,AnalyticalDevelopmentandQualityControl

MS in Chemistry, Analytical Chemistry, or a related field with 8–10+ years of relevant experience, or PhD in a similar discipline with 5–8+ years of relevant experience, Demonstrated leadership experience managing analytical CMC activities across multiple programs, expertise in analytical method development, validation, transfer, and lifecycle management in compliance with ICH guidelines, General understanding of key analytical methods (e. g. , HPLC/UPLC, GC, KF, ICP-MS, IC, XRPD, PSD) with the ability to interpret data and guide technical decisions, Proven experience authoring, reviewing, and approving analytical sections of regulatory submissions (INDs, IMPDs, NDAs, and global filings), Significant experience supporting NDA submissions and interacting with regulatory agencies, technical writing skills for preparation of validation reports, transfer reports, investigation reports, and regulatory documentation, Ability to effectively communicate and justify analytical control strategies within cross-functional teams (Quality, Regulatory, Process Development) and with external stakeholders, Experience overseeing external partners (e. g. , CDMOs) and managing outsourced analytical activities, leadership, communication, and project management skills in a cross-functional environment, technical writing and authorship skills, with the ability to prepare, review, and approve analytical reports and CMC documentation to support internal decision-making and knowledge management, Applicants should be legally entitled to work for any employer in the US