Director, CMC Project Management

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Director, CMC Project Management based in United States.

• Partner with Technical Operations leadership and CMC functional leads to develop and maintain integrated CMC development plans aligned with program and organizational objectives.
• Build and maintain complex project plans, timelines, and Gantt charts covering process and analytical development, manufacturing, stability studies, regulatory CMC deliverables, clinical supply, and other Technical Operations activities.
• Establish activity dependencies, identify critical-path milestones, and monitor progress against approved project plans, commitments, and deliverables.
• Proactively identify schedule risks, resource constraints, dependencies, scope changes, and potential delays, escalating issues to appropriate leadership and functional stakeholders.
• Maintain project dashboards and deliver concise, accurate status updates for management and cross-functional project teams.
• Plan and facilitate CMC and Technical Operations meetings, including preparation of agendas, documentation of decisions, and tracking of action items and owners.
• Maintain decision and action-item logs and follow up with stakeholders to drive timely resolution and completion.
• Serve as a central project-management interface between Technical Operations/CMC and Clinical, Regulatory, Quality, Finance, Legal, and Program Management functions.
• Coordinate CMC timelines with broader clinical and regulatory development plans and facilitate effective communication across project teams.
• Support portfolio planning, management reporting, executive reviews, and preparation of materials for senior leadership.
• Develop and maintain CMC project budgets and forecasts in collaboration with functional leaders.
• Track vendor and CDMO invoices against contracts, statements of work, purchase orders, milestones, and agreed payment schedules.
• Maintain accurate financial trackers and support annual budgeting, reforecasting, and long-range CMC financial planning.
• Establish and maintain organized electronic document-management structures and CMC SharePoint environments covering project plans, development reports, manufacturing and analytical documentation, stability information, regulatory materials, contracts, meeting records, budgets, and vendor documentation.

• Significant project management experience within CMC, Technical Operations, pharmaceutical, biotechnology, or a closely related life sciences environment.
• Demonstrated ability to manage complex, cross-functional CMC development programs involving multiple workstreams, stakeholders, vendors, and dependencies.
• Strong understanding of CMC development activities, including process and analytical development, manufacturing, stability, regulatory CMC, and clinical supply.
• Proven experience developing and maintaining detailed project plans, integrated timelines, Gantt charts, dashboards, risk logs, decision logs, and action-item trackers.
• Strong organizational and prioritization skills, with the ability to manage multiple complex initiatives and critical-path activities simultaneously.
• Experience managing project budgets, forecasts, vendor contracts, statements of work, purchase orders, and invoices.
• Experience working directly with CDMOs and other external development or manufacturing partners.
• Strong cross-functional collaboration skills and the ability to serve as an effective interface between technical, operational, financial, regulatory, and corporate functions.
• Excellent written and verbal communication skills, including the ability to provide concise and actionable updates to senior leadership.
• Demonstrated ability to identify risks and dependencies proactively, resolve issues, and escalate matters appropriately.
• Strong attention to detail and a disciplined approach to project documentation, information management, and version control.
• Experience with project-management and collaboration tools such as Gantt-based planning systems, dashboards, SharePoint, or comparable platforms.
• Ability to operate effectively in a fast-paced, evolving environment and bring structure to complex and ambiguous situations.

• Annual salary range of $240,000–$260,000.
• Full-time, remote position based in the United States.
• Opportunity to work across high-impact biopharmaceutical development programs and collaborate with senior Technical Operations and CMC leaders.
• Broad cross-functional exposure spanning Clinical, Regulatory, Quality, Finance, Legal, Program Management, and external CDMO partners.
• Significant ownership of project planning, execution, financial tracking, risk management, and executive reporting.
• Opportunity to contribute to portfolio.