Design Transfer Manager

📋 Description

• Lead design transfer activities from R&D to manufacturing for an NGS IVD/PMA assay.
• Plan, execute, and document transfer plans to meet milestones.
• Lead test method development, characterization, and validation.
• Manage a multidisciplinary team of scientists; provide mentorship.
• Conduct risk management (FMEA) and mitigate hazards.
• Align with QA/Regulatory to ensure design transfer compliance and launch.

🎯 Requirements

• Advanced degree in molecular biology or related field; PhD preferred.
• 6-8 years post-PhD biotech experience; or >10 years post BS/MS.
• 4+ years managing scientists/research staff.
• Hands-on NGS experience; DNA/RNA biology; methylation knowledge desirable.
• Proven design transfer track record; strong design control and validation.
• Familiar with ISO, CLSI, FDA; GLP/GMP; strong cross-functional leadership.

🎁 Benefits

• Compensation range: $137,100–$171,300 USD
• Annual performance incentive bonus
• Long-term equity awards
• Health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and holidays