🛠 Tech Stack

💼 About This Role

You'll lead process development and validation for our cfDNA-based multi-cancer detection platform in a GMP/ISO 13485 environment. Your core impact is ensuring consistent quality and yield across diagnostic manufacturing operations. This role offers the chance to shape US operations at a rapidly growing company.

🎯 What You'll Do

• Lead process design, optimization, and validation for molecular diagnostic manufacturing.
• Establish process control strategies and monitor systems for consistent quality.
• Oversee production campaigns ensuring compliance with GMP and ISO 13485.
• Conduct root cause analyses and implement corrective actions.

📋 Requirements

• BS, MS, or PhD in Bioengineering, Chemical Engineering, or Molecular Biology.
• 6–8 years of experience in IVD, NGS, or biopharma manufacturing engineering.
• Expertise in process validation, equipment qualification, and deviation management.
• Strong understanding of GMP, ISO 13485, and FDA/CLIA regulations.

✨ Nice to Have

• Experience with tech transfer or scale-up.
• Background in aseptic workflows or robotic liquid handling.
• Certification in Lean or Six Sigma methodologies.

🎁 Benefits & Perks

• 🏖️ 22 days PTO with carryover option.
• 🎂 Company Holidays plus your Birthday off.
• 🏥 Medical, dental, vision insurance plus STD, LTD, 401(k).
• ⏰ Flexible work schedule.