CMC Project Manager
Core
Leading and managing regulatory affairs CMC projects to ensure successful execution and delivery of project objectives for drug development programs.
Role type
CMC Project Manager
Builds
Drug development programs/projects
Domain
Biotechnology / Immunology / Clinical Research
Deliverable
client delivery
Required skills
CMC project management, biologics experience, critical path analysis, risk mitigation, scenario simulation, stakeholder relationship management, project planning and budgeting
Preferred skills
CMC team coordination, vendor relationship management, MS Project, Power BI, Planisware
Responsibilities
Achieve project goals including timelines, budget, and scope; translate scientific strategy into CMC project plans; track and report key milestones and decision points; coordinate delivery of critical path items; perform critical path analysis and risk assessments; lead project team meetings and document actions.
Seniority
Mid-level, hands-on IC