Lead CMC and quality program management for biologics development, coordinating cross-functional teams and external partners to ensure regulatory submissions and clinical supply readiness.
What you’ll do
Lead CMC and Quality program management across biologics development
Coordinate cross-functional teams and external partners
Manage project plans, risks, resources, and budgets
Support regulatory submissions (BLA, MAA) and clinical supply readiness
What you’ll need
Bachelor's degree in life sciences, chemistry, engineering, or related field
8+ years in pharmaceutical/biotech industry with CMC development and late-stage biologics experience
Proven leadership of global matrixed cross-functional teams in regulated environment
Strong skills in integrated project planning, risk management, and budget oversight
Proficient in MS Office suite and electronic document management systems
Excellent communication, facilitation, and presentation skills
Original job description
Summit Therapeutics is seeking an Associate Director to lead CMC and Quality program management across biologics development, from early clinical phases through BLA submission and post-approval changes. The role coordinates cross-functional teams and external partners, manages plans and risks, and supports regulatory submissions and clinical supply…