Senior Manager, Development and Design Transfer

📋 Description

• Lead and coordinate design transfer activities from R&D to manufacturing
• Plan and manage activities and studies from late-stage development to launch
• Contribute to design documents, such as reagent stability plans, design inputs, design outputs
• Participate in risk management activities (such as hazard analysis, FMEA)
• Work closely with bioinformatics/statistics groups in aligning study designs and acceptance criteria
• Develop and execute detailed design transfer plans

🎯 Requirements

• Advanced degree in molecular biology or related discipline; PhD preferred, Master's or Bachelor's
• 6-8 years of post PhD biotech industry experience or >10 years of post BS/MS biotech experience
• At least 4 years managing a team of scientists and research associates
• Hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biology
• Proven track record of successful design transfer for assays and medical devices
• Strong understanding of assay development, design control, analytical validation, and manufacturing

🎁 Benefits

• Comprehensive medical, dental, vision, life and disability plans
• Free testing for employees and immediate family
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits