Principal Scientist, Analytical Operations

Role: Principal Scientist, Analytical Operations at Gilead, serving as QC Lead for small molecule clinical development, overseeing cGMP analytical testing and strategy. Responsibilities: define and implement QC strategies aligned with CMC and regulatory standards; manage method validation, transfer, specifications, and testing at internal and external labs; ensure compliance with cGMP, FDA, EMA, ICH; provide technical input for regulatory submissions; and lead cross-functional collaborations across Analytical Development, Manufacturing, and Quality Assurance. Requirements: 8+ years' experience with MS, PhD, or PharmD in analytical chemistry or related field; extensive expertise in small molecule QC testing, specifications, and regulatory CMC documentation; experience managing external testing labs; strong leadership, communication, and project management skills. HighValue: small molecule pharmaceuticals, clinical development, cGMP compliance, regulatory filings, and cross-functional leadership within GxP environments.