Senior Scientist (IVD Product Development)

TL;DR

Senior Scientist (IVD Product Development): Design, develop, and validate automated high-throughput NGS assays for early cancer detection with an accent on reagent and process optimization under design controls. Focus on managing technical projects, ensuring regulatory compliance for FDA submission, and collaborating cross-functionally to meet quality standards.

Location: San Carlos, CA (onsite)

Salary: $138,100 - $172,600 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
• Execute experiments, perform data analysis, and optimize reagents and processes
• Collaborate with cross-functional teams on assay specifications, equipment, and quality metrics
• Write protocols, reports, SOPs, lead verification, and train lab operations
• Identify improvements to workflows and reduce turnaround time for patient samples

Requirements

• BA/BS +8 years, MS +5 years, or PhD +3 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 and design controls
• Strong knowledge of nucleic acid extraction, PCR, NGS library prep, hybrid capture
• Hands-on with reagent QC, high-throughput automation, liquid handlers
• Design/execute studies: stability, guard banding, reproducibility, repeatability, QC
• Data analysis with JMP required; excellent communication and cross-functional collaboration

Nice to have

• Coding skills in Python or R
• Liquid handler programming experience

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