Director, CMC Project Management

• Support end-to-end CMC project execution for biologics
• Integrate strategy and execution across process development, manufacturing, supply chain, quality, and regulatory functions
• Own and drive integrated CMC project plans, timelines, and milestones across all development stages
• Lead core CMC team meetings and ensure alignment, accountability, and follow-through actions
• Partner closely with the CMC Lead in a joint leadership model for each program
• Drive execution of agreed-upon strategy
• Manage cross-functional dependencies
• Ensure decisions are implemented efficiently
• Manage internal and external document reviews and approvals, including liaising with Finance on budgets
• Monitor external partner performance and elevate risks as needed
• Continuously assess program progress and proactively manage risks, gaps, and contingencies
• Act as a primary program interface with CDMOs and major external vendors
• Drive alignment on timelines, deliverables, and issue resolution
• Integrate activities across Technical Operations, Regulatory, Finance, and Legal
• Leverage AI-enabled tools and scalable program management practices to strengthen planning, risk management, visibility, and execution
• Prepare concise, data-driven updates for executive leadership in partnership with the CMC Lead
• Communicate CMC project status, risks, and mitigation plans

• MS or BS in a scientific or engineering discipline required
• PMP certification is strongly preferred
• Minimum 10 years of relevant experience, including 6 years managing CMC programs for biologics
• Solid understanding of biologics CMC, including development, manufacturing, and regulatory requirements
• Experience working with CDMOs and external partners
• Experience applying AI tools or advanced analytics to program management workflows
• Familiarity with project management platforms and data visualization tools
• Demonstrated success operating in a lean, operationally efficient environment
• Ability to engage deeply with cross-functional teams and effectively partner with CMC Lead
• High ownership, execution leadership, and ability to drive results in a lean environment with a lean, but evolving structure
• Agile and resourceful, comfortable navigating ambiguity and shifting priorities
• Strong stakeholder management and issue resolution skills
• Ability to partner effectively with technical leadership while maintaining execution ownership
• Strong technical fluency with the ability to translate CMC discussions into clear plans, actions, timelines, and risks
• Clear, concise communicator with strong executive presence

Demonstrates expertise in managing CMC programs for biologics, integrating cross-functional strategies, and driving execution in a lean environment. Proficient in stakeholder management, risk assessment, and utilizing AI tools for program management.

• CMC Program Management
• Biologics Development
• PMP Certification
• Stakeholder Management
• AI Tools Application

• Biologics CMC
• Program Management
• Risk Management
• Data Visualization
• Regulatory Requirements
• Manufacturing Processes
• Project Management
• Cross-Functional Collaboration
• Budget Management
• Lean Operations

• Clear Communication
• Execution Leadership
• Problem Solving
• Adaptability
• Team Engagement

• PMP Certification

• CDMO
• Technical Operations
• Regulatory Affairs
• Supply Chain Management
• Quality Assurance

• Project Management Platforms
• AI-Enabled Tools
• Data Analytics Tools