Design Transfer Scientist

Responsibilities

• Own and execute process validations, stability studies, and study protocols
• Support test method development, characterization, and Test Method Validation (TMV)
• Lead risk management activities including FMEAs
• Manage change control workflows and evaluate operational impact of design changes
• Investigate product or process deviations and perform root cause analysis
• Implement Corrective and Preventive Actions (CAPA)
• Coordinate with automation engineering, bioinformatics, and laboratory operations
• Partner with Supply Chain to establish raw material and consumable pipelines

Requirements

• BA/BS with 8+ years experience, MS with 5+ years, or PhD with 3+ years in assay development and automation
• Experience with automated high-throughput NGS assays
• Hands-on expertise with NGS workflows (DNA/RNA extraction, targeted enrichment, library preparation)
• Knowledge of Design Controls, QMS, and regulatory standards (FDA, ISO 13485, CLSI)
• Proficiency in statistical analysis using Minitab or JMP

Preferred Qualifications

• Prior experience in IVD product development, scale-up, or manufacturing
• Experience operating or optimizing 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, aiming to make personalized genetic testing a standard of care.