In conjunction with internal subject matter experts and consultants, the Director will be responsible for identifying CMC Gaps and implementing cross functionally aligned CMC strategy to support late stage and commercial CMC regulatory submissions, coordinating the planning and on-time completion of CMC activities through BLA filing, PLI and approval. Develop, drive and maintain detailed CMC Plan and Major Milestones activities across Technical Operations, plan and track content draft, review and delivery dates against identified timelines, proactively identify and prioritize program risks and develop and monitor risk mitigation-contingency plans.