Sr. Director, CMC Project Management
New
J
JobgetherBiopharmaceutical development
Full-time, remote position based in the United States.Full-TimeDirector
Salary240,000 - 260,000 USD per year
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Job Details
- Experience
- Significant project management experience within CMC, Technical Operations, pharmaceutical, biotechnology, or a closely related life sciences environment.
- Required Skills
- Project ManagementSharePointRisk Management
Requirements
- Significant project management experience within CMC, Technical Operations, pharmaceutical, biotechnology, or a closely related life sciences environment.
- Experience managing complex, cross-functional CMC development programs with multiple workstreams, stakeholders, vendors, and dependencies.
- Strong understanding of process and analytical development, manufacturing, stability, regulatory CMC, and clinical supply.
- Experience developing and maintaining project plans, integrated timelines, Gantt charts, dashboards, risk logs, decision logs, and action-item trackers.
- Experience managing project budgets, forecasts, vendor contracts, statements of work, purchase orders, and invoices.
- Experience working directly with CDMOs or other external development or manufacturing partners.
- Experience with Gantt-based planning systems, dashboards, SharePoint, or comparable project-management and collaboration platforms.
- Ability to manage multiple complex initiatives and critical-path activities simultaneously.
- Ability to identify risks and dependencies proactively, resolve issues, and escalate matters appropriately.
- Strong cross-functional collaboration and ability to interface across technical, operational, financial, regulatory, and corporate functions.
- Excellent written and verbal communication skills, including concise updates to senior leadership.
- Strong attention to detail and disciplined project documentation, information management, and version control.
- Ability to operate effectively in a fast-paced, evolving environment and bring structure to complex situations.
Responsibilities
- Develop and maintain integrated CMC development plans aligned with program and organizational objectives.
- Build project plans, timelines, and Gantt charts for development, manufacturing, stability, regulatory CMC, clinical supply, and Technical Operations activities.
- Establish dependencies, identify critical-path milestones, and monitor progress against plans and deliverables.
- Identify schedule risks, resource constraints, scope changes, and potential delays; escalate issues to leadership and stakeholders.
- Maintain project dashboards and provide status updates to management and project teams.
- Plan and facilitate CMC and Technical Operations meetings, documenting decisions and tracking action items and owners.
- Coordinate CMC timelines with broader clinical and regulatory development plans and connect Technical Operations with cross-functional functions.
- Support portfolio planning, management reporting, executive reviews, and senior leadership materials.
- Develop project budgets and forecasts, track vendor and CDMO invoices, and support budgeting and financial planning.
- Maintain organized electronic document-management structures and CMC SharePoint environments.
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