Project Manager, CMC

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive
. As a global leader in robotic-assisted surgery and minimally invasive care
, our technologies-like the da Vinci surgical system and Ion
-have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare
, you'll find your purpose here.

The Fluorescence Imaging Team at Intuitive is developing agents designed to work seamlessly with Intuitive's robotic platforms and Firefly imaging technology. The agents have the potential to highlight critical anatomy and disease in real time-giving surgeons clearer information at the moment decisions matter most and helping improve outcomes for patient s.

The CMC Project Manager serves as a strategic and operational partner to Chemistry, Manufacturing, and Controls (CMC) leadership, providing integrated project management for development programs from clinical development through regulatory submission, launch readiness, and commercialization. The role translates CMC strategies and technical decisions into coordinated cross‑functional project plans that enable effective execution.

Reporting to the Program Management & Operations organization, the CMC Project Manager partners with CMC, Manufacturing, Analytical Development, Quality, Regulatory Affairs, Supply Chain, Clinical Supply, Clinical Development, Commercial, Finance, Procurement, and external partners to integrate timelines, risks, dependencies, budgets, and technical decisions into unified project plans.

• Support the Program Management & Operations team in implementing CMC governance processes, including governance forums, operating cadences, decision pathways, program reporting, and the RAID framework.
• Facilitate CMC governance by preparing materials, maintaining RAID and decision logs, documenting actions and decisions, monitoring follow-through, and escalating cross‑functional risks and decision requests, as appropriate.
• Develop, maintain, and communicate detailed CMC project plans for assigned programs, including milestones, dependencies, critical‑path activities, document workflows, key cGMP deliverables, stability pulls and reports, regulatory commitments, and cross‑functional deliverables.
• Coordinate execution across Drug Substance, Drug Product, Manufacturing, Analytical Development, Quality, Regulatory Affairs, Supply Chain, Clinical Supply, and external partners, providing hands‑on project management support to assigned CMC work streams.
• Monitor execution and proactively identify schedule impacts, resource constraints, cross‑functional dependencies, technical and operational risks, and potential budget impacts.
• Facilitate the development and implementation of mitigation plans.
• Develop and apply governance and project reporting materials that communicate milestone performance, critical‑path status, key risks, decision requests, budget impacts, and recommended actions to leadership and PM&O teams.
• Support regular functional‑area…