Project Manager, CMC

Company DescriptionIt 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 DescriptionFluorescence Imaging at Intuitive SurgicalThe 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 patients.Job DescriptionPrimary Function of PositionThe 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 ResponsibilitiesSupport 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.QualificationsQualificationsBachelor’s 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 coordinationStrong 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 QualificationsExperience supporting NDA Module 3 preparation and submissionExperience 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 InformationDue 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 NoticesU.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 government’s 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 employee’sstart 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 candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s 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.SummaryType: Full-timeFunction: General BusinessExperience level: AssociateIndustry: Medical Device