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United States
Remote only
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.
This role will drive the planning, coordination, and execution of CMC activities across complex biopharmaceutical development programs.
You will translate CMC strategy into integrated, actionable project plans spanning development, manufacturing, analytical, stability, regulatory, and clinical supply activities.
The position serves as a central project-management partner connecting Technical Operations with clinical, regulatory, quality, finance, legal, and program teams.
You will oversee critical-path milestones, dependencies, risks, budgets, vendor activities, and project documentation.
The role requires strong collaboration with CMC functional leaders and external CDMOs while maintaining clear visibility into program progress.
You will also support executive reporting and portfolio planning by providing concise, accurate insights into timelines, resources, financials, and risks.
This is an opportunity to bring structure, accountability, and operational discipline to high-impact development programs in a fast-paced biotech environment.
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 planning and the successful advancement of development programs.
Collaborative environment with exposure to complex CMC strategy and operational execution.
