Sr. Bioinformatics Scientist

Veracyte seeks a Senior Bioinformatics Scientist to lead the design, development, and validation of regulated genomic assays. The role combines NGS expertise with assay optimization, pipeline development, and regulatory compliance knowledge to transform biological data into clinical insights.

Responsibilities

• Lead bioinformatics design, development, and validation for new and existing diagnostic products
• Drive study design and analysis for assay development in collaboration with cross-functional teams
• Develop scalable production-grade workflows for high-throughput NGS data analysis
• Ensure compliance with CAP/CLIA, FDA, and IVDR standards throughout development lifecycle
• Mentor junior bioinformatics team members and communicate findings to stakeholders

Requirements

• Deep expertise in NGS technologies and genomic assay development
• Demonstrated experience with CAP/CLIA and IVD product regulatory environments
• Strong proficiency in analytical pipeline development and optimization
• Experience with AWS and containerized environments for bioinformatics workflows
• Knowledge of statistical and machine learning methods for assay performance evaluation
• Understanding of FDA and regulatory compliance standards in diagnostics