Opportunity Description
- Lead integrated CMC planning across Drug Substance, Drug Product, Analytical, Quality, Regulatory, and Supply Chain, aligning deliverables, timelines, and priorities with clinical and regulatory objectives.
- Drive execution of CMC plans to ensure alignment with program milestones and overall development timelines.
- Provide end-to-end project management support across the product lifecycle, from development through commercialization and commercial manufacturing.
- Develop, maintain, and manage integrated project timelines in Planisware or Smartsheet, clearly defining dependencies, milestones, and critical path activities.
- Facilitate cross-functional Product Team meetings, including agenda development, decision documentation, and action item tracking.
- Proactively identify, assess, and manage program risks and issues; main...
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