Project Manager, CMC

Intuitive•Sunnyvale, CA

About The 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.

Requirements

Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, Business, or a related field, or equivalent experience.
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.

Nice To Haves

An advanced degree is preferred.
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.

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.