This leader will serve as the technical owner for outsourced drug substance and drug product manufacturing, with accountability for process robustness, scalability, process validation, continued process verification, and lifecycle management in close partnership with External Manufacturing, Quality, Regulatory CMC, Supply Chain, and manufacturing partners. Provide technical guidance for process troubleshooting, deviation investigations, root-cause analyses, CAPAs, change controls, process performance trending, and technical impact assessments in collaboration with Quality and external partners to support validation, launch, and commercial supply.