Project Manager - CMC (Program Manager)
- Defined project strategies and managed key deliverables and risks to ensure successful plant execution while aligning with portfolio objectives.
- Established and monitored comprehensive project plans, timelines, and budgets, collaborating with project managers to drive accountability and progress reporting.
- Contributed to global discussions, driving value creation throughout development and launch phases.
- Coordinated end-to-end CMC operations, including lead assignments, PQ, and PV batches, ensuring seamless phase transitions.
- Prepared and reviewed CDMO selection documents and developed guidelines for efficient outsourcing operations.
- Managed CDMO relationships, proactively monitoring operations to ensure supply commitments and mitigate risks.
- Developed and tracked project timelines from kickoff through production, ensuring on-time delivery across product lines.
- Created and distributed detailed reports (8–10 per month), providing actionable insights and updates on daily, weekly, and monthly project activities.
- Regularly communicated with DS representatives to resolve issues, track progress, and determine actionable steps.
- Facilitated stakeholder meetings to align on deliverables, schedules, and conflict resolution strategies.
- Maintained budget adherence through effective planning and diligent expense tracking.
- Oversaw Full-Time Equivalent (FTE) submissions in Budget Navigator on monthly and biannual timelines, coordinating with core functional teams.
- Executed Confidential Disclosure Agreements (CDA) and service agreements in collaboration with CDMOs, legal, and cross-functional teams, ensuring alignment with organizational goals.
- Cultivated strong stakeholder relationships, aligning services with objectives and strategies while providing consultative support.
- Anticipated stakeholder needs and collaborated on enhancing or developing service offerings.
- Championed knowledge sharing within the team and advocated for continuous improvement throughout project lifecycles.
- Managed New Chemical Entity (NCE) manufacturing activities and Discovery Chemistry projects, coordinating global communications from inception to material shipment while ensuring regulatory compliance in logistics.