Associate Director, CMC, Program Management

📋 Description

• Lead program management for one or more CMC programs, developing and maintaining integrated plans
• Partner with CMC asset leads and functional subject matter experts to translate CMC strategy into
• Lead CMC team meetings and governance processes, including agendas, minutes, action-item tracking
• Proactively monitor critical-path activities, identify strategic and operational risks, assess
• Coordinate CMC deliverables across Regulatory, Quality, Analytical Development, Technical
• Develop concise program dashboards and status reports that provide visibility into milestones

🎯 Requirements

• Bachelor's degree in life sciences, chemistry, engineering, pharmaceutical sciences, or a related
• Eight to ten years of relevant experience in the pharmaceutical or biotechnology industry
• Demonstrated understanding of CMC development, regulatory CMC requirements, and cGMP-compliant
• Experience building and managing complex, integrated plans across multiple technical workstreams
• Proven ability to lead cross-functional teams and drive execution through influence in a matrixed
• Experience proactively identifying, communicating, escalating, and managing program risks, issues