Senior Scientist, Analytical Development and Quality Control - Early Phase

Role: Senior Scientist leading analytical development and QC in biopharma drug development, with focus on IND-enabling and early clinical studies. Responsibilities: develop and validate chromatographic and analytical methods, characterize drug substance and product attributes, manage internal and external testing labs, oversee stability studies, and contribute to regulatory documentation. Requirements: advanced degree in Chemistry, Pharmaceutics, or related; 8+ years (PhD) or 14+ years (BS/MS) of industrial CMC experience; expertise in HPLC method development and validation; experience overseeing vendor activities; strong knowledge of cGMP, ICH guidelines, and stability programs. HighValue: expertise in biopharma CMC, drug characterizations, stability, and regulatory submissions; relevant for biologics or small molecule therapeutics in early clinical stages; vendor oversight; domestic and international travel. WorkSetup: onsite at Brisbane, CA; travel required.