Executive Director, CMC Development – Technical Operations

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $290k - $300k / year

⏰ Full Time

🔴 Lead

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jasper Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🛡️ Insurance

Healthcare • Consulting • Insurance

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

• Serve as CMC Program Leader for assigned clinical-stage development programs • Translate Technical Operations and product-development strategy into integrated CMC development plans and execute them successfully • Provide hands-on leadership for designated programs • Support Analytical Development and Quality Control (AD/QC) across the Jasper product portfolio • Lead technical activities conducted through CDMOs and CROs • Partner with Supply Chain, Device/Combination Product, Quality, Regulatory Affairs, Clinical Operations, and Project Management to ensure CMC readiness for clinical development • Serve as primary point of contact for all CMC activities supporting the ongoing Phase 2 clinical program in China • Plan and execute local/regional clinical drug supply and device activities • Coordinate with Clinical Operations, Supply Chain, and external partners to ensure timely clinical supply availability • Support drug product manufacturing, release, packaging/labeling, shipment, inventory, and expiry management for local clinical trials • Identify and resolve CMC and supply-related issues affecting clinical trial timelines • Support device and combination-product activities for assigned clinical programs • Serve as KP701 CMC Program Lead • Translate clinical and regulatory objectives into executable CMC activities, milestones, timelines, budgets, and deliverables • Oversee drug substance and drug product development and manufacturing

🎯 Requirements