Director, Analytical Development

Manage development and tracking of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation, and site transfer under aggressive timelines. Coordinate with internal Analytical, CMC, QA, Regulatory, Project Management teams, and external CROs/CMOs to support contractor site investigations for OOS/OOT and deviations. Review SOPs, test methods, specifications, and validation protocols for infigratinib formulation. Advance programs to key decision points in preparation for regulatory submission, approval, and post-approval commitments. Assist in data generation, analysis, and regulatory filings while ensuring activities align with project objectives. Perform data review and stability tracking.