Senior Scientist, Analytical Development & Quality Control

Role: Senior Scientist in Analytical Development & Quality Control (ADQC) supporting small-molecule and peptide drug development from early to late-stage programs. Responsibilities: develop, optimize, and validate analytical methods for drug substance and drug product, including impurity analysis, degradant characterization, and stability; establish phase-appropriate control strategies and specifications; troubleshoot analytical issues; manage stability and reference standards; review CDMO data for compliance and data integrity; author regulatory documentation sections; lead continuous improvement initiatives; represent ADQC in cross-functional meetings. Requirements: PhD or MS in Analytical Chemistry or related discipline; 5+ years supporting CMC development; expertise in UHPLC and detection technologies (UV, MS, etc.); extensive experience with peptides, ADCs, or complex biologics preferred; knowledge of cGMP/GLP and regulatory standards; strong communication, project management, and leadership skills. HighValue: focus on peptide and small-molecule drugs, early to late-stage development, analytical method lifecycle management, CDMO collaboration, cGMP compliance. WorkSetup: on-site in Newark, CA, 4 days/week; domestic and international travel as needed.