CMC Project Manager: Drug Development & Launch

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

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.