Project Manager, CMC

Job description

Job 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…
• 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,…
• 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…
• 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…
• 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…

Job requirements

• Bachelor’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…
• 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.
• Experience supporting NDA Module 3 preparation and submission
• Experience managing CDMOs (and other suppliers)