Manager, Analytical Sciences - Commercial

Role: Manager of Analytical Sciences overseeing analytical strategies for Praxis's commercial small molecule portfolio. Main objectives include ensuring testing compliance, supporting lifecycle management, and maintaining inspection readiness. Responsibilities involve executing analytical methods, leading method transfer and validation, managing analytical activities at CDMOs, reviewing documentation, supporting investigations of OOS/OOT results, assessing risks related to manufacturing and supply changes, and contributing to regulatory submissions. Requirements: Bachelor's in Chemistry or related field with 7+ years of GMP-regulated analytical chemistry experience, supporting small molecule drug substances and/or products. Skilled in analytical method transfer, validation, lifecycle management, and data review per ALCOA+ and CFR Part 11 standards. Preferred skills include experience with US/EU cGMP, regulatory submissions, and inspections. High-Value: Focus on small molecule drug substances, oral dosage forms, lifecycle and post-approval changes, regulatory compliance, and cross-functional partnership with QC, Regulatory, Manufacturing, and CMC teams. Work setup: Remote with 20-30% travel to Boston and CDMO sites during validation, investigations, and inspections.