Lead technology transfer of scaled manufacturing processes to contract manufacturers, oversee scale-up and initial commercial production, define process parameters and controls, monitor batch trends, troubleshoot yield and quality issues, and drive improvements in yield, cycle time, and cost. The role partners with R&D, quality, and CMO engineering teams and conducts process hazard analyses and risk assessments. Travel to partner sites is approximately 30%.

Leads the manufacturing readiness and new product introduction process from lab scale through commercial launch. Responsibilities include managing stage-gate reviews, integrated launch plans, scale-up, technology transfer, qualification, contract manufacturing coordination, quality integration, risk resolution, and cross-functional collaboration across R&D, engineering, quality, supply chain, and commercial teams.