Principal Scientist, Analytical Operations

Role: Principal Scientist, Analytical Operations (QC Lead) at Gilead, overseeing cGMP analytical testing for small molecule clinical programs. Responsibilities: develop and implement QC strategies, manage method validation and transfer, oversee testing at internal and external labs, ensure compliance with cGMP and regulatory standards, and support regulatory submissions. Collaborates with cross-functional teams including Analytical Development, Manufacturing, and Regulatory. Qualifications: 10+ years' experience with BS, 8+ years with MS, or 5+ years with PhD or PharmD, with deep expertise in small molecule analytical chemistry, QC, and regulatory requirements. High-Value: focus on small molecule clinical development, phase-appropriate QC strategies, cGMP compliance, regulatory submission support, and external lab management. Work setup: not specified.