💼 About This Role

You'll lead the NGS-based cancer screening assay development for DELFI Diagnostics, driving innovative assays from design to validated IVD products. Reporting to the CTO, you'll shape product strategy and ensure reliable, manufacturable solutions for early cancer detection.

🎯 What You'll Do

• Own assay development strategy across LDT and IVD programs
• Lead formal design reviews and partner with Systems Engineering
• Oversee reagent development and automated process scale-up
• Lead design transfer and manufacturing readiness

📋 Requirements

• 12+ years in IVD/LDT assay development
• PhD or MS in Molecular Biology or related discipline
• Hands-on expertise in analytical validation of multi-marker assays
• Deep knowledge of IVD regulatory frameworks (FDA, ISO, IVDR)

✨ Nice to Have

• Direct leadership of FDA PMA submissions
• Experience in reagent development and SPC in manufacturing
• Track record in high-growth biotech companies

🎁 Benefits & Perks

• 🏖️ Flexible hybrid work
• 🏥 Health coverage
• 💰 Competitive compensation
• 📈 Stock options

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 90 min