• Manage operational and technical support of small molecule CDMOs to deliver on late phase clinical and commercial production. • Lead CDMOs to implement CMC strategy in manufacturing including but not limited to efforts to optimize manufacturing processes, implement process changes, and reduce manufacturing costs. • Provide on-site CDMO oversight, as needed, to accomplish clinical and routine, commercial production goals. • Provide SME impact assessments on deviation investigations, support CAPAs, and manage proactive initiatives and change controls, as required. • Lead review and approval for technical reports, risk assessments, batch records, SOP’s, etc. required for cGMP manufacturing. • Develop, track, and monitor production data for CMO during clinical manufacturing and PPQ to mature to continued process verification (CPV) during commercial manufacturing. • Represent External MFG / MSAT on cross functional teams (internal and external) for late stage / commercial CDMO. • Act as the internal project team lead for CDMO. • Ensure operational robustness and efficiency through management and tracking of manufacturing metrics and KPIs. • Support authoring and review of CMC sections of health authority submissions. • Provide immediate response support, as required. • Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches.