Project Manager, CMC

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale, CA seeks a CMC Project Manager to serve as a strategic and operational partner to CMC leadership, delivering integrated project management for development programs from clinical development through regulatory submission, launch readiness, and commercialization.

The role translates CMC strategies into coordinated cross‑functional plans, aligning timelines, budgets, risks, and decisions across multiple functions to enable effective execution and governance.

Qualifications

• Bachelor's degree requirement as stated in the posting.
• Advanced degree preferred as per the posting.

Responsibilities

• 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 workstreams.
• 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 budget management in coordination with CMC Functional Area Team Leads and PM&O by tracking actual and forecasted accruals, invoices, purchase orders, and inputs to the Annual Operations Budget Planning Cycle.
• Support CDMO and supplier oversight by: incorporating vendor updates into project plans and governance materials; tracking purchase orders, change orders, invoices, key contract terms, and performance commitments; and coordinating business reviews and operational follow‑up across internal functions.
• Drive adoption of standardized project management tools, templates, dashboards, reporting practices, and workflow automation that improve portfolio visibility, consistency, and execution.

Skills

Project management

Education

Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, Business, or related field

Advanced degree preferred

Job description

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.

Job Description

Fluorescence Imaging at Intuitive Surgical

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.

Job Description

Primary Function of Position

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.

Roles and Responsibilities

• 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 workstreams.
• 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 budget management in coordination with CMC Functional Area Team Leads and PM&O by tracking actual and forecasted accruals, invoices, purchase orders, and inputs to the Annual Operations Budget Planning Cycle.
• Support CDMO and supplier oversight by: incorporating vendor updates into project plans and governance materials; tracking purchase orders, change orders, invoices, key contract terms, and performance commitments; and coordinating business reviews and operational follow‑up across internal functions.
• Drive adoption of standardized project management tools, templates, dashboards, reporting practices, and workflow automation that improve portfolio visibility, consistency, and execution.

Qualifications

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, Business, or a related field, or equivalent experience. An advanced degree is preferred.