- Build, maintain and communicate integrated CMC timelines aligned with clinical development and regulatory milestones.
- Run CMC team meetings, including agendas, minutes, decisions and action-item tracking through closure.
- Maintain the program’s source of truth for deliverables, owners and due dates.
- Track risks, issues, assumptions and dependencies across CMC and cross-functional workstreams, escalating and driving resolution or mitigation.
- Partner with CMC technical leads to translate technical strategy into executable project plans.
- Coordinate CDMO/CMO deliverables, meeting cadence and document tracking with technical and quality leads.
- Maintain CMC budget and spend trackers and support purchase order, invoice and accrual reconciliation.
- Track CMC regulatory submission authoring, review and approval milestones with Regulatory Affairs.
- Develop and maintain timelines, dashboards and status reports for internal stakeholders and leadership.
- Prepare materials for governance and leadership reviews, including program updates and key decision points.
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