We are seeking an experienced and strategic CMC Team Leader to provide cross-functional leadership for Chemistry, Manufacturing, and Controls (CMC) activities across clinical and commercial-stage biologic products. This individual will serve as the integrated CMC lead for our late-stage autologous cell therapy programs and will partner closely with Technical Operations, Process Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Program team lead to advance products from development through commercialization. Responsibilities: CMC Strategy & Program Leadership Lead the overall CMC strategy for assigned program(s) from development through registration and commercialization. Serve as leader of the cross-functional CMC team, aligning activities across Process Development, Analytical Development, Quality, Regulatory, and Supply Chain to deliver to program objectives. Develop integrated CMC development plans including process development, analytical development, manufacturing, comparability, process characterization, validation, and lifecycle strategy. Drive cross-functional decision-making on technical risks, timelines, development priorities, and resource needs. Ensure CMC plans are aligned with clinical, regulatory, and commercial objectives. Regulatory & Filing Support Partner with Regulatory Affairs to develop the CMC regulatory strategy for global submissions. Provide CMC leadership and content oversight for IND/CTA amendments, BLA/MAA filings, responses to agency questions, and post-approval changes. Lead preparation for health authority interactions related to CMC. Ensure consistency between technical development strategy and regulatory submission strategy. Commercialization & Lifecycle Readiness Support planning and execution of commercialization readiness activities including process validation, PPQ/CPV strategy, control strategy, and manufacturing readiness. Provide strategic leadership for CMC aspects of launch readiness, supply continuity, and lifecycle management. Support technical transfer, process scale-up, and manufacturing network strategy as applicable. Cross-Functional Leadership Partner closely with: Process Development / MSAT Analytical Development Quality Assurance / Quality Control Regulatory Affairs Supply Chain Program Management Project Management Drive alignment across internal teams and, if needed, external CDMO partners. Escalate key risks, tradeoffs, and recommendations to senior leadership in a concise and actionable manner. Governance & Communication Lead CMC team meetings, governance forums, and strategic planning discussions. Develop clear executive-level summaries of program status, risks, mitigation plans, and critical path activities. Present program updates to leadership, governance committees, and external stakeholders as needed. Qualifications: