• Create and maintain CMC project plans to deliver on critical late phase or commercial CMC strategy and activities. • Work with the Quality Product Lead (QPL) to lead and drive the cross-functional CMC strategy for BLA-enabling milestones to ensure seamless transition to commercial manufacturing. • Develop and oversee mitigation projects from the CMC risk register in collaboration with stakeholders across Quality, Process Sciences, Process Development, Analytical Development, External Manufacturing, MSAT, and Regulatory Affairs. • Anticipate technical and operational challenges and provide clear, data-driven recommendations, including risks and tradeoffs, to senior leadership to enable timely and informed decision-making. • Prioritize and drive continuous improvements into the project plan across external network. • Collaborate with CMC PM to ensure programs are within budget and timeline and to provide regular updates. • Collaborate with key stakeholders (Process Sciences, Process Development, MSAT, Ext Manufacturing, Quality (QA, QC, PQL), and Analytical Development) to ensure investigations are complete, mitigation actions aligned, and a clear, integrated path forward is defined to support priority CMC needs. • Communicate overall health of CMC efforts, especially technical or operational risks, to support regulatory strategy. • Review Module 3 content to support regulatory filings (INDa, AR, CTAs, BLA, etc.). • Manage team of TPLs.