Senior Director, CMC Project Management

Job not on LinkedIn

🕒 September 21

🇺🇸 United States – Remote

💵 $240k - $260k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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This company has sponsored H1B visas in the past.

👻 Ghost score 7%

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Jasper Therapeutics

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Jasper Therapeutics is a biotechnology company focused on targeting mast cells and stem cells to treat chronic diseases. Their mission is to make safer and potentially curative therapy possible for patients in need. The company is developing new therapies using their targeted anti c-Kit monoclonal antibody, Briquilimab, aimed at depleting mast cells and diseased stem cells for conditions such as chronic urticaria and asthma, as well as to improve outcomes for stem cell transplants in rare diseases.

📋 Description

• Support the planning, coordination, and execution of CMC activities across development programs • Partner with CMC functional leads, cross-functional teams, and CDMOs to translate CMC strategy into integrated project plans • Develop and maintain integrated CMC project plans, complex timelines, and Gantt charts • Track CMC activities, milestones, deliverables, dependencies, commitments, risks, issues, and scope changes • Identify schedule risks, resource constraints, dependencies, and potential delays; escalate issues to leadership • Maintain project dashboards and provide status updates to management and project teams • Plan, organize, and facilitate internal CMC/Technical Operations meetings • Prepare meeting minutes and maintain action-item and decision logs • Serve as the project-management interface between Technical Operations/CMC and Clinical, Regulatory, Quality, Finance, Legal, and Program Management • Coordinate CMC timelines with clinical and regulatory development plans • Support portfolio planning, management reporting, and executive-level reviews • Develop and maintain CMC project budgets and forecasts • Review and track vendor/CDMO invoices against contracts, statements of work, purchase orders, milestones, and payment schedules • Maintain financial trackers and support budget planning, reforecasting, and long-range financial planning • Establish and maintain organized CMC electronic filing and document-management structures • Organize CMC SharePoint folders and maintain filing conventions for project, manufacturing, analytical, stability, regulatory, contract, meeting, budget, and vendor documentation

🎯 Requirements

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