Senior Scientist, R&D Design Transfer & Product Development

Responsibilities

• Lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations
• Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols
• Support test method development, characterization, and Test Method Validation (TMV)
• Lead Risk Management activities including FMEAs to identify and mitigate product risks
• Establish and maintain Design History Files (DHF) and Device Master Records (DMR)
• Lead change control activities to evaluate the impact of design changes on-market products
• Investigate product or process deviations and implement Corrective and Preventive Actions (CAPA)
• Partner with Supply Chain to establish raw material and consumable pipelines

Requirements

• PhD in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or related field with 4+ years of industry experience
• OR Master’s degree with 7+ years of industry experience
• OR Bachelor’s degree with 10+ years of industry experience
• Hands-on expertise in Next-Generation Sequencing (NGS) workflows (DNA/RNA extraction, targeted enrichment, or library preparation)
• Expertise in DNA molecular biology techniques such as PCR, qPCR, and multiplex PCR
• Ability to design, execute, and document laboratory experiments
• Proficiency in basic statistical analysis
• Strong cross-functional communication and interpersonal skills

Preferred Qualifications

• Knowledge of Design Controls, QMS, and regulatory standards (FDA, ISO 13485, CLSI)
• Experience authoring study plans, protocols, and 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 like Hamilton or Tecan

About the Company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The company aims to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier, more targeted interventions.