Manager, Analytical Development
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.