Senior Scientist, R&D Design Transfer & Product Development

The role

The Senior Design Transfer Scientist leads the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role involves planning and executing design transfer activities, performing data analysis, and ensuring compliance with regulatory and quality standards.

What you will do

• Plan and execute process validations, stability studies, and study protocols
• Perform data analysis and author final reports
• Support test method development, characterization, and Test Method Validation (TMV)
• Generate manufacturing specifications
• Lead Risk Management activities including FMEAs
• Establish and maintain Design History Files (DHF) and Device Master Records (DMR)
• Lead change control activities to evaluate impact of design changes
• Investigate product or process deviations and perform root cause analysis
• Implement Corrective and Preventive Actions (CAPA)
• Partner with Supply Chain to establish raw material and consumable pipelines

Required qualifications

• PhD in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field with 4+ years of relevant industry experience; OR
• Master’s degree in the fields above with 7+ years of relevant industry experience; OR
• Bachelor’s degree in the fields above with 10+ years of relevant industry experience
• Hands-on expertise in Next-Generation Sequencing (NGS) workflows such as DNA/RNA extraction, targeted enrichment, or whole genome library preparation
• Deep expertise with other DNA molecular biology techniques such as PCR, qPCR and multiplex PCR
• Ability to own a study from start to finish including designing experiments, executing in the lab, analyzing data and documenting results
• Must be able to perform basic statistical analysis
• Excellent cross-functional communication and interpersonal skills
• Ability to present complex technical data clearly to non-technical audiences
• Exceptional time management and organizational skills

Nice to have

• Knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments
• Experience authoring study plans, protocols and study reports
• Experience with statistical software (such as JMP)
• Prior experience in IVD product development or commercialization
• Experience in manufacturing, scale up, and Quality Control (QC)
• Experience with automated liquid handling platforms (e.g., Hamilton, Tecan)

Benefits

• Comprehensive medical, dental, vision, life and disability plans
• Free testing for employees and their 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, software engineers and many other professionals.