- Lead program- and portfolio-level CMC development planning and execution for multiple small-molecule assets, from initial tox supplies through scale-up across drug substance and drug product.
- Develop and own detailed CMC project plans and risk registers, and track development strategies, timelines, and deliverables.
- Serve as the day-to-day primary contact for external CDMOs across China, the EU, and the US.
- Oversee CRO and CDMO planning, manufacturing campaign and batch execution timelines, and documentation deliverables.
- Organize and chair cross-functional and CDMO meetings, and track agendas, minutes, actions, and decisions.
- Communicate project status, risks, and mitigation strategies to internal teams and external partners.
- Manage the CMC proposal, purchase order, and change order pipeline for assigned projects.
- Maintain multi-year CMC budget forecasts and historical spend models, and oversee commitments, accruals, and variance analysis.
- Operate and improve controlled, multi-stage CMC document review workflows.
Project Management