- Job type
- Not listed
- Work mode
- Remote
- Level
- Director
- Department
- Other
- Experience
- 5+ years experience
- Posted
- Aug 4, 2026
About the role
What You'll Do
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.
Responsibilities
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.
Where You'll Work
Remote with 30% travel anticipated
Who You Are
MS in Organic Chemistry, Analytical Chemistry, Pharmaceutical Science.
5+ years’ experience in the contract research or pharmaceutical/biotech industry.
Demonstrated abilities in the development and application of analytical assay, impurity, and in-vitro (dissolution) release.
Experience in high performance liquid chromatography and physicochemical properties (solubility, solid state, physical testing), methods development, drug substance and drug product
Knowledge of cGMP regulations, including compendial (USP, EP, JP) and guidance documents.
Working knowledge of FDA, EMA and ICH guidelines.