Small Molecule CMC Leader - Senior Director
Core
Lead CMC (Chemistry, Manufacturing and Controls) for small molecule, biopharm, or CGT medicines from Commit to Phase 2 through Phase 3/commercial process development, file review, and launch.
Role type
Senior Director, CMC Project Leadership
Builds
P3/commercial processes, clinical supplies, regulatory files, and launch readiness for small molecule, biopharm, or CGT medicines.
Domain
Biopharmaceuticals / Small Molecule / CGT / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC strategy development, process scale-up, tech transfer, regulatory submission authoring, cross-functional matrix leadership, governance management, lifecycle planning, supply chain integration, risk mitigation, stakeholder influence with health authorities.
Preferred skills
Line management of directors, CMC/SC due diligence, systems and process updates.
Technologies
CMC/SC matrix tools, governance platforms, contract development and manufacturing networks (CDMOs).
Responsibilities
Lead CMC from C2P2 to commercial launch; define drug substance/product/analytical/manufacturing strategies; manage CMC budgets >£30M and peak sales >£500M; secure PPQ and PAI readiness; transfer knowledge to Medicine Supply Chain Leader; lead international multi-disciplinary teams including external collaborators.
Seniority
Senior Director, hands-on IC with mentorship responsibilities.
