CMC Project Manager — Drug Development & Launch Readiness

Intuitive; Sunnyvale (CA); On-site; USD 128,000 - 151,000; Full time

Job summary

Intuitive Surgical is seeking a CMC Project Manager to lead cross-functional programs from clinical development through NDA submission and launch readiness. You will translate CMC strategies into integrated plans and partner with Regulatory, Quality, Manufacturing, and Supply Chain to drive on-time delivery.

You will manage budgets, RAID, timelines, and risks, mentor teams, and implement governance frameworks to improve portfolio visibility and execution across Drug Substance, Drug Product, and

Qualifications

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, Business, or related field; advanced degree preferred.
• Minimum 8 years of combined experience in CMC development and project management in pharma.
• Cross-functional coordination with CMC, Regulatory, Quality, Clinical Development, Supply Chain, and Commercial teams.
• Experience with timeline management, risk/issue management, budget tracking, vendor coordination.

Responsibilities

• Provide integrated project management for development programs from clinical development through NDA submission and launch readiness.
• Translate CMC strategies into coordinated cross-functional project plans with timelines, risks, budgets, and decisions.
• Develop and maintain detailed CMC project plans including milestones, dependencies, and deliverables.
• Coordinate execution across Drug Substance, Drug Product, Manufacturing, Analytical Development, Quality, Regulatory Affairs, Supply Chain, and external partners.

Skills

Cross-functional coordination

Timeline management

Risk management

Budget tracking

Vendor coordination

Education

Bachelor’s degree in Life Sciences, Pharma, Engineering

Tools

Smartsheet

Coupa

Ivalua

SAP

Ariba

Job description

Intuitive Surgical is seeking a CMC Project Manager to lead cross-functional programs from clinical development through NDA submission and launch readiness. You will translate CMC strategies into integrated plans and partner with Regulatory, Quality, Manufacturing, and Supply Chain to drive on-time delivery.

You will manage budgets, RAID, timelines, and risks, mentor teams, and implement governance frameworks to improve portfolio visibility and execution across Drug Substance, Drug Product, and