Scientist, IVD Product Development (NGS)

Location: San Carlos, California, United States

Salary: $116,800–$146,000 USD annually

Company

hirify.global develops cell-free DNA testing and molecular diagnostics for oncology, women’s health, and organ health.

What you will do

• Design, develop, and validate automated high-throughput NGS assays for FDA and other regulatory submissions.
• Develop assays for use in a commercial single-site IVD CLIA laboratory.
• Manage technical projects, timelines, deliverables, protocols, reports, and SOPs.
• Design and execute verification, stability, reproducibility, repeatability, guard-banding, and QC studies.
• Collaborate with clinical laboratory, quality assurance, automation engineering, bioinformatics, statistics, laboratory operations, and product management teams.
• Train clinical laboratory scientists and improve production workflows to reduce turnaround time for patient samples.

Requirements

• BA/BS with 5+ years, MS with 3+ years, or PhD with 1+ years of experience in assay development and automation for the life science industry.
• Demonstrated experience developing and validating automated protocols for CLIA laboratories.
• Experience with IVD product development and design controls.
• Strong knowledge of nucleic acid extraction, PCR, NGS library preparation, hybrid capture, reagent preparation, and quality control.
• Hands-on experience optimizing and troubleshooting high-throughput automated assays using liquid-handler robots.
• Experience working in regulated laboratory environments under CLIA/CAP, with required data analysis using JMP and Excel.

Nice to have

• Python or R coding skills.
• Liquid-handler programming experience.

Culture & Benefits

• Cross-functional collaboration in a fast-paced product development environment.
• Annual performance incentive bonus and long-term equity awards.
• Medical, dental, vision, life, and disability benefits.
• 401(k) with company match, paid time off, company holidays, commuter benefits, and wellness programs.
• Fertility care benefits and free testing for employees and immediate family members.