Your Role: Lead a cross-functional CMC team with functional members/sub-team leaders from Technical Operations, Regulatory and Quality, including cell culture, purification, formulations, drug product, bioanalytics, analytical development, Quality Control, device development, Quality Assurance, CMC Regulatory, Regulatory Operations, CMC Program Management, and Supply Chain / Logistics. Acts as overall product/process expert for the project and provides technical and scientific expertise on major project topics, drives and leads technical and scientific discussion and alignment within the CMC team and in cross-functional governance and manufacturing advisory board meetings.