Design Transfer Scientist (NGS)

TL;DR

Design Transfer Scientist (NGS): Leading the transition of IVD NGS assays from R&D into scalable clinical operations with an accent on process validation, technical documentation, and regulatory compliance. Focus on building robust production pipelines, executing TMV, and managing cross-functional workflows to ensure high-quality diagnostic manufacturing.

Location: Must be based in San Carlos, CA

Salary: $116,160 - $145,200 USD

Company

hirify.global is a global leader in cell-free DNA testing, specializing in oncology, women’s health, and organ health diagnostics.

What you will do

• Own and execute process validations, stability studies, and technical reports.
• Support test method development and validation (TMV) to establish manufacturing specifications.
• Lead risk management activities, including FMEAs, to mitigate product risks.
• Manage change control workflows and document operational impacts of design changes.
• Investigate process deviations and implement sustainable CAPA solutions.
• Coordinate with automation, bioinformatics, and supply chain teams to ensure project execution.

Requirements

• BA/BS with 8+ years, MS with 5+ years, or PhD with 3+ years of experience in assay development.
• Hands-on expertise with NGS workflows, including DNA/RNA extraction and library preparation.
• Operational knowledge of Design Controls, QMS, and regulatory standards like FDA and ISO 13485.
• Proven track record in authoring validation protocols and technical reports.
• Proficiency in statistical analysis software such as Minitab or JMP.
• Must be authorized to work in the United States.

Nice to have

• Prior experience in IVD product development or commercial Quality Control.
• Experience optimizing automated liquid handling platforms like Hamilton or Tecan.

Culture & Benefits

• Comprehensive health benefits including medical, dental, and vision.
• 401(k) retirement plan with company match.
• Annual performance incentive bonus and long-term equity awards.
• Generous paid time off and company holidays.
• Fertility care benefits and free testing for employees and immediate families.