Director of CMC Project Management
Job Summary
Supporting end-to-end CMC project execution in a hybrid environment, the full-time salaried Director of CMC Project Management will manage integrated project plans, timelines, and milestones for biologics while collaborating closely with the CMC Lead to ensure strategic objectives are met across various functions.
Key responsibilities
- Own and drive integrated CMC project plans, timelines, and milestones across all development stages
- Lead core CMC team meetings to ensure alignment, accountability, and follow-through actions
- Continuously assess program progress and proactively manage risks, gaps, and contingencies
Required qualifications
- MS or BS in a scientific or engineering discipline required
- PMP certification is strongly preferred
- Minimum 10 years of relevant experience, including 6 years managing CMC programs for biologics
- Solid understanding of biologics CMC, including development, manufacturing, and regulatory requirements
- Experience applying AI tools or advanced analytics to program management workflows
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