About the job
Location Requirement:
This position can be based on either the U.S. West Coast (preferably near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The role mandates occasional travel between both locations to facilitate cross-site collaboration and meet business needs.
The Analytical Development and Science Technology Lead is tasked with:
Acting as a seasoned subject matter expert (SME) and scientific authority to develop compliant, robust, and applicable analytical methods (IPC, DS, and DP) along with associated Quality Systems, including specifications for small molecule products.
Bringing extensive prior experience to aid in the transition of a product from phase 3 CMC development to commercial readiness while adhering to all relevant regulatory and legislative requirements.
Overseeing and managing both development and routine analytical activities at Contract Laboratories/Manufacturing Organizations (CLO/CMO), including release testing and stability studies, while investigating and resolving issues and queries.
Contributing to the design of submission-enabling stability study programs, assessing shelf life, and ensuring the relevance of analytical methods.
Continuously verifying methods through analysis of trend data, establishing and reviewing method lifecycle to maintain, develop, and validate analytical methods supporting quality and process comprehension.
Designing and leading analytical transfer workstreams of drug substance and drug product transfers from development to commercial sites and between commercial sites, including method qualifications, validations, and training of external laboratories.
Supporting the development, refinement, and implementation of robust and compliant product control strategies by ensuring analytical method capabilities, specifications, and stability data are fully aligned with quality and process understanding.
Leading internal activities related to external manufacturing, such as assessments of analytical changes, major/critical deviations, risk assessments, and Corrective and Preventive Actions (CAPAs).
Overseeing the establishment and maintenance of reference materials and ensuring responsibility for product-specific method standards and qualified materials (critical reagents), including organizing the shipping of samples and reagents.
Writing and reviewing applicable sections in registration filings.