Director, Process Sciences, CMC

Director, Process Sciences, CMC responsible for leading late-stage process development and commercialization efforts at CDMOs to support CytomX’s clinical-stage ADC program CX-2051, and for leading CMC BLA readiness by authoring dossiers and preparing health authority responses while developing analytical control strategies for product life cycle management. Responsibilities include directing late-stage process characterization and optimization for monoclonal antibodies, cytotoxic payloads, linkers, and ADC; defining regulatory-ready analytical control strategies; managing analytical comparability assessments and process improvements; driving BLA readiness by authoring and endorsing CMC dossiers (IND/CTA and BLA/MAA) per ICH guidelines; preparing CMC teams to respond to regulatory inquiries; and partnering with Analytical and QA to maintain cGMP manufacturing and quality standards. Also highlights collaboration, leadership, and a strong emphasis on regulatory affairs, QA, Manufacturing, and Supply Chain across global product launches.