Project Manager, CMC

Fluorescence Imaging at Intuitive Surgical

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

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 :

Qualifications

• Bachelors degree in Life Sciences Pharmaceutical Sciences Chemistry Engineering Business or a related field or equivalent experience. An advanced degree is preferred.
• Minimum 8 years of combined experience in CMC development and project management within the pharmaceutical industry supporting small-molecule development programs from clinical development through NDA submission and launch readiness.
• Demonstrated success in cross-functional coordination with CMC Regulatory Affairs Quality Clinical Development Supply Chain and Commercial teams to support program planning governance and decision-making.
• Expertise in timeline management risk and issue management resource coordination budget tracking vendor coordination
• Strong communication facilitation and presentation skills with the ability to deliver clear actionable project updates and drive alignment without direct authority.
• Proficiency with Smartsheet including detailed project planning dashboards reporting and workflow automation.

Preferred Qualifications

• Experience supporting NDA Module 3 preparation and submission
• Experience managing CDMOs (and other suppliers)
• PMP or comparable project management certification.
• Familiarity with procurement contracting and financial management systems such as Coupa Ivalua SAP Ariba or equivalent.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time