This individual will serve as the Company's analytical development subject matter expert and primary technical representative with external laboratories, Contract Development and Manufacturing Organizations (CDMOs), and Contract Research Organizations (CROs), supporting all phases of clinical development with a focus on Phase 3 clinical supply, process characterization and validation, comparability, specifications, stability, method qualification/validation and transfer, regulatory submissions, PPQ, and preparation for commercial manufacturing. The Director, Analytical Development will provide technical and strategic leadership for analytical development, characterization, method lifecycle management, and testing strategies supporting the Company's biologics programs, with primary responsibility for supporting late-stage clinical development and advancing programs toward commercial readiness.