Job Duties: Responsible for regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing related activities, including scale-up of candidate compounds to support candidate selection during drug discovery, from preclinical development through commercialization. Identification, selection, and management of Contract Manufacturing Organizations (CMOs) for process optimization and cGMP manufacture of DS in support of ongoing clinical programs. Delivery of robust, scalable, and cost-effective phase-appropriate manufacturing of DS that meets or exceeds quality and regulatory requirements. Implement phase-appropriate process characterization, identify critical quality attributes, and implement controls, including selection and justification of regulatory starting materials (RSMs) to ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards and to ensure consistency of DS quality. Lead the characterization of late phase programs according to the principles of QbD (mapping studies, DOEs) to identify critical quality attributes and critical process parameters (including edge of failure and proven acceptable ranges) and implement DS Control Strategy to support NDAs/MAAs. Support management of RSMs and DS supply chain and logistics in support of demand for clinical studies and commercial products. Develop and execute plans for the primary stability registration and validation batches of DS as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations. Lead process validation programs to support commercialization. Prepare and/or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; represent the company as the DS expert before U.S. and European regulatory authorities. Prepare, review, or approve cGMP batch records, CMC regulatory and Quality documents. Prepare technical reports, publications, and oral presentations. Up to 50% domestic and foreign travel is required. Percentage of foreign and domestic travel can vary by project needs.