Responsible for managing the 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. Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and consultants, as well as with external CROs/CMOs counterparts. Manage critical analytical review of SOPs, test methods and specifications for raw materials/intermediates/drug substance/drug product, development/verification reports, validation protocols/reports, method transfers, COAs and stability summaries. Support contractor site investigations pertaining to OOS/OOT and deviations.
Support Analytical (CMC) activities associated with the formulation of infigratinib.
Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to rapidly advance programs to key decision points, in preparation of regulatory submission, approval and post-approval commitments.
Assist in data generation and analysis.
Ensure analytical development activities are aligned with the project’s overall objectives.
Assist in regulatory filings.
Perform data review & stability tracking.