Staff Scientist (IVD Product Development)

TL;DR

Staff Scientist, IVD Product Development (NGS Oncology): Design, develop, and validate automated high-throughput NGS assays for early cancer detection with an accent on reagent and process optimization under design controls for regulatory submission. Focus on managing technical projects, cross-functional collaboration, data analysis, and ensuring quality standards for CLIA labs.

Location: San Carlos, CA

Salary: $157,300–$196,600 USD

Company

Global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health.

What you will do

• Design, develop, and validate automated high-throughput NGS assays for commercial CLIA labs
• Manage technical projects, timelines, deliverables, and mentor junior staff
• Design and execute complex experiments, perform data analysis using JMP, R, or Excel
• Collaborate with assay development, clinical lab, QA, automation, bioinformatics, and product teams
• Write protocols, reports, SOPs, and train lab operators
• Lead verification, identify process improvements, and contribute to workflow optimization

Requirements

• MS with 11+ years or PhD with 8+ years in assay development and automation for life sciences
• Track record in developing and validating automated protocols for CLIA labs
• Experience with IVD product development, design controls, and NGS biology/processes
• Strong knowledge of nucleic acid extraction, PCR, NGS library prep, hybrid capture
• Hands-on with reagent prep, QC, high-throughput automated assays, liquid handlers
• Excellent communication, organization, and cross-functional collaboration skills

Nice to have

• Coding skills in Python or R
• Liquid handler programming experience
• Experience designing stability, guard banding, reproducibility studies, QC methods

Culture & Benefits

• Annual performance bonus and long-term equity awards
• Comprehensive health benefits (medical, dental, vision), 401(k) with match
• Generous PTO, company holidays, wellness, and work-life benefits
• Free testing for employees and families, fertility care, pregnancy/baby bonding leave
• Commuter benefits and employee referral program