Director, Analytical Development

Role: Analytical Development Scientist focused on supporting the formulation and analytical testing of infigratinib drug substance and product, ensuring compliance with regulatory standards. Responsibilities: develop and track testing methods (in-process, release, stability), review SOPs, test methods, specifications, and validation reports; support investigations for OOS/OOT deviations; coordinate with internal teams (CMC, QA, Regulatory) and external CROs/CMOs to advance programs and prepare regulatory submissions; perform data analysis and stability monitoring. Requirements: MS in Organic/Analytical Chemistry or Pharmaceutical Science; 5+ years in pharma/biotech with expertise in analytical assays, impurity profiling, dissolution testing, and high-performance liquid chromatography; working knowledge of cGMP, FDA, EMA, ICH guidelines. High-Value: support for formulation development of infigratinib, regulatory filings, remote work with 30% travel, biopharma focus on small molecules, drug substance and product, cGMP compliance. Collaboration with cross-functional teams and external partners essential, with a focus on accelerating early to late-stage development.