Director, CMC Product Lead
Core
Strategic oversight and execution of CMC strategies for multiple assets across therapeutic areas from first-in-human to pivotal studies, ensuring alignment with TPP and QTPP.
Role type
Director, CMC Product Lead
Builds
CMC Development Plans and actionable CMC tasks/milestones for biopharmaceutical assets
Domain
Biotechnology / Pharmaceutical / Drug Development
Required skills
CMC strategy, Technical Development, Manufacturing, Supply Chain, Quality, Process Development, CMC Regulatory, Cross-functional leadership, Strategic planning, Budgeting, Resource allocation
Preferred skills
PhD in Biochemistry/Chemistry/Biology/Pharmaceutical Sciences, Executive influence, Financial acumen, Technical storytelling, Thought leadership in program strategy
Technologies
None stated
Responsibilities
Define and communicate strategic CMC Development Plans; Translate platform strategy into actionable CMC tasks; Serve as primary point of accountability for CMC plan; Engage in technical discussions and own technical roadmap; Lead CMC team in discussions with key leadership; Identify and address cross-functional gaps and risks; Manage resource and financial management of the team
Seniority
Director, Executive Leadership