This individual will serve as the Company's upstream manufacturing subject matter expert and primary technical representative with Contract Development and Manufacturing Organizations (CDMOs/CMOs), ensuring reliable clinical supply while driving manufacturing execution, process characterization, technology transfer, process validation/PPQ, continued process verification, regulatory inspection readiness efforts, and preparation for commercial manufacturing. Director will serve as the upstream process SME across development, manufacturing, and partner closely with internal and consultant CMC resources, Quality, Regulatory Affairs, Supply Chain, Program Management, and external manufacturing partners to ensure robust, compliant, scalable, and reliable production of biologic drug substance.