Director CMC Program Lead

Position Summary 
The Cell Therapy CMC Program Lead Director is responsible for leading cross-functional matrix teams within Cell Therapy Development & Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files. This position reports into the Head of CMC Cell Therapy Portfolio Strategy and interfaces directly with the CMC Program Steering Committee for escalations, strategic decisions, and reporting. This position is based in either Santa Monica, CA or Gaithersburg, MD. 

Responsibilities 

• Build, grow, and mature the CMC function within Cell Therapy Development & Operations and serve as a central point of accountability for CMC portfolio execution. 

• Must possess strong communication skills and must be savvy working with technology, process development, analytical development, manufacturing and business partners across the organization in a collaborative way. Demonstrates excellent stakeholder management skills with matrixed functional teams (Manufacturing, Process & Analytical Development, Quality, Regulatory, Supply Chain). 

• Prepare project team and steering committee materials related to their assigned projects and ensure project work aligns with established practices, policies, and processes. Provide regular updates to senior management and key team members with program status, risks, mitigation plans, and recommendations for strategic decisions. 

• Owns risk management (identification, escalation, resolution, mitigation) for all CMC activities and ensures effective resolution via collaboration, matrix leadership, and formal escalation pathways.  

• Lead the strategic planning and execution of CMC programs for cell therapy products from early development through commercialization with clear transition management between early and late-stage milestones as defined by governance stage gates. 

• Collaborate cross-functionally with R&D, Process & Analytical Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain and other departments to drive program success and alignment with business objectives. Facilitates seamless cross-functional integration, aligning diverse technical and operational input to achieve CMC deliverables, investment decisions, and key milestones. 

• Develop and lead program timelines, budgets, and resources to meet project achievements and deliverables. Coordinates and secures functional resources in partnership with functional leaders, maintains updated RACI for every stage gate, and ensures team alignment on objectives. 

• Identifies and anticipates CMC-related risks/constraints to timing and resources and proactively communicates/escalates via RACI-defined channels. 

• Provide strategic guidance and oversight for CMC-related regulatory submissions, including IND, BLA, and other regulatory filings. Ensures program deliverables meet regulatory and compliance requirements at each development stage; partners with regulatory experts and functional reps for aligned submissions.