Design Transfer Scientist (NGS)

TL;DR

Design Transfer Scientist (NGS): Leading the transition of IVD Next-Generation Sequencing assays from R&D to Operations with an accent on process validation, regulatory compliance, and risk management. Focus on executing IQ/OQ/PQ protocols, managing design history files, and driving cross-functional collaboration to ensure seamless product commercialization.

Location: Must be based in Austin, TX

Salary: $103,700 - $129,600 USD

Company

hirify.global is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health through personalized genetic diagnostics.

What you will do

• Plan and execute process validations (IQ/OQ/PQ), stability studies, and test method validations.
• Lead risk management activities including FMEAs and maintain Design History Files (DHF).
• Investigate product or process deviations and implement corrective and preventive actions (CAPA).
• Manage change control activities to evaluate the impact of design changes on market products.
• Collaborate with supply chain teams to establish raw material and consumable pipelines.
• Present technical data and status updates to cross-functional stakeholders.

Requirements

• Ph.D. with 2+ years, Master’s with 5+ years, or Bachelor’s with 8+ years of relevant industry experience.
• Hands-on expertise in NGS workflows or DNA molecular biology techniques like PCR and qPCR.
• Ability to own studies from design and lab execution to data analysis and reporting.
• Strong understanding of Design Controls, QMS, and regulatory standards like FDA and ISO 13485.
• Excellent communication skills for presenting complex technical data to non-technical audiences.
• Must be located in Austin, TX.

Nice to have

• Experience with statistical software such as JMP.
• Prior experience in IVD product development or commercialization.
• Background in manufacturing, scale-up, and Quality Control (QC).
• Experience with automated liquid handling platforms like Hamilton or Tecan.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability insurance plans.
• Free genetic testing for employees and immediate family members.
• Fertility care benefits and pregnancy/baby bonding leave.
• 401k retirement benefits and commuter assistance.
• Generous employee referral program.