Description
Intuitive is seeking an experienced analytical chemistry professional to provide strategic and technical support for small-molecule drug programs in late-stage development through regulatory submission. The role oversees external CDMO analytical resources, manages method transfer, optimization, validation, and quality control, reviews protocols and data, assesses analytical risks, leads Phase 3/PPQ validation, and authorizes and responds to CMC Module 3 sections and regulatory information requests. The position requires a Ph.D. or M.S. in analytical chemistry or a related field, extensive small-molecule drug substance and drug product experience, late-stage development expertise, ICH and cGMP knowledge, and strong technical writing and regulatory communication skills.
