• Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP) • Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS) • Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers • Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension • Manage reference standard program (i.e., qualification, storage, inventory, distribution) • Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications • Development and validation of analytical methods and verification of compendial methods • Able to communicate results both internally and externally through oral and written updates and formal reports as necessary • Provide analytical support for API and Drug Product process development • Authoring of development reports, protocols, and methods • Support quality audits as a technical representative and contribute to authoring of audit reports