FSP RA - Client Dedicated - CMC Project Manager
Core
CMC Project Manager leading Chemistry, Manufacturing, and Controls development for therapeutic antibodies, ensuring projects move forward within and across functions.
Role type
Senior IC CMC Project Manager
Builds
CMC development programs for therapeutic antibodies
Domain
Biopharmaceuticals / Biologics
Required skills
CMC project management, process development, analytical development, technical transfer, dossier development, clinical manufacturing, project strategy, critical path analysis, risk mitigation, budget forecasting, contract modification management, regulatory submission preparation, matrix leadership
Preferred skills
biologics experience, CMC team/vendor management, business development collaboration, proposal development
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Translate scientific strategy into CMC project plans, track and report key milestones, perform critical path analysis and risk mitigation, coordinate delivery of critical path items, prepare regional regulatory submissions, provide regulatory strategy advice, manage project budgeting, identify out-of-scope contract activities, collaborate on pricing and proposals, provide matrix leadership to junior members, ensure compliance with SOPs and WPDs
Seniority
Senior, hands-on IC