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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