Director, CMC Project Management

The Director, CMC Project Management will be responsible for managing activities related to CMC Planning. 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. The successful candidate must possess a technical understanding of the inter-disciplinary nature of cell therapy development, demonstrated with previous experience. The position requires timeline and deliverable management with close collaboration with Operation, Quality and Regulatory, and requires collaboration with program management to provide sufficient details into the Integrated Project Plan (IPP).

The position reports to the Vice President, Technical Operations Strategy, with a dotted line to Program Management (PMO).

Key Responsibilities

• In support of the CMC strategy, translate the strategy into project plans with defined deliverables and deadlines, and drive the cross-functional teams and manage inter-dependencies across Technical Operations functions to complete them.
• 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
• Facilitating CMC GAP Assessment, Risk Analysis, strategy discussions and other meetings and operational mechanisms to drive cross-functional decision making, and successful execution of program plans for facilitating CMC Planning activities.
• Lead data-driven decision-making to facilitate timely, objective recommendations for continuation, acceleration, re-prioritization, redesign or termination of projects,