Senior Manager, Development and Design Transfer

The role

This person will lead and coordinate the transfer of products from R&D into Operations. They will manage a multidisciplinary group of scientists to plan, execute, and document design transfer activities for a next generation sequencing assay.

What you will do

• Plan and manage activities and studies from late-stage development to launch
• Contribute to design documents including reagent stability plans, design inputs, and design outputs
• Participate in risk management activities such as hazard analysis and FMEA
• Develop and execute detailed design transfer plans
• Lead and coordinate design transfer activities from R&D to manufacturing
• Lead test method development, characterization, and validation
• Lead process validations
• Manage a team of scientists to coordinate execution of studies
• Provide technical mentorship and decision-making support for the team
• Partner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs

Required qualifications

• Advanced degree in molecular biology or related discipline
• 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 workflows
• Extensive knowledge of quality and regulatory standards (ISO, CLSI, FDA)
• Ability to establish and follow SOPs with knowledge of GLP/GMP guidelines
• Experience with process validations for single-site oncology assays
• Proficiency in experimental design, statistical data analysis, and technical problem-solving
• Demonstrated ability to lead multidisciplinary teams and provide mentorship

Nice to have

• PhD is preferred
• Experience authoring study plans, protocols, and study reports is highly desirable

Benefits

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

About the company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The team consists of statisticians, geneticists, doctors, laboratory scientists, business professionals, and software engineers.