Senior Scientist, R&D Design Transfer & Product Development (NGS)

Location: San Carlos, CA, United States

Salary: $136,600–$170,700 USD base pay annually, plus additional compensation and benefits.

Company

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

What you will do

• Lead the transfer of in vitro diagnostic NGS assays from R&D to Operations.
• Plan and execute IQ/OQ/PQ process validations, stability studies, study protocols, and final reports.
• Support test method development, characterization, validation, and manufacturing specification generation.
• Lead risk management, including FMEAs, and maintain Design History Files and Device Master Records.
• Manage change controls, investigate deviations, perform root cause analysis, and implement CAPA.
• Partner with Supply Chain and cross-functional stakeholders on materials, consumables, project status, data, and technical proposals.

Requirements

• PhD with 4+ years, Master’s degree with 7+ years, or Bachelor’s degree with 10+ years of relevant industry experience in molecular biology, cell biology, biotechnology, biochemistry, or a related field.
• Hands-on experience with NGS workflows such as DNA/RNA extraction, targeted enrichment, or whole-genome library preparation, and/or advanced PCR, qPCR, or multiplex PCR expertise.
• Ability to design and execute experiments, perform basic statistical analysis, and document study results from start to finish.
• Strong cross-functional communication, presentation, organizational, and time-management skills.
• Knowledge of Design Controls, QMS, FDA, ISO 13485, CLSI, and GLP/GMP environments is highly desired.
• Experience authoring study plans, protocols, and reports; statistical software such as JMP is highly desired.

Nice to have

• Experience in IVD product development or commercialization.
• Manufacturing, scale-up, and Quality Control experience.
• Experience with automated liquid-handling platforms such as Hamilton or Tecan.

Culture & Benefits

• 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 and work-life benefits.
• Fertility care benefits and free testing for employees and immediate families.