Scientist, IVD BioDevelopment (NGS)

Location: Austin, TX, United States; onsite role.

Salary: $98,300–$122,900 USD annually.

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 laboratory efforts and independently plan, execute, analyze, troubleshoot, and present moderate- to high-complexity experiments.
• Conduct development, verification, validation, and analytical performance studies in accordance with CLSI guidance.
• Coordinate study design, sample size justification, acceptance criteria, and analysis with biostatistics and bioinformatics teams; perform basic analysis using Excel and JMP.
• Author and review SOPs, protocols, study reports, and transfer documents, and contribute to design inputs, outputs, and risk assessments under design control.
• Communicate progress, results, risks, and next steps to colleagues and senior management; document research in an electronic quality management system.
• Train junior team members on SOPs and laboratory workflows and provide technical troubleshooting support to laboratory operations.

Requirements

• Bachelor’s degree in molecular biology, cellular biology, immunology, or a related field plus 5–8 years of related experience; or an MS degree plus 4+ years; or a PhD plus 2+ years.
• Knowledge of high-throughput NGS workflows or other clinical genetic testing applications.
• Strong interpersonal, analytical, problem-solving, communication, and presentation skills, with meticulous attention to detail.
• Proactive, solutions-oriented approach with demonstrated success in collaborative and individual projects.
• Knowledge of design verification and validation processes compliant with U.S. and E.U. regulatory standards, including FDA, IVDR, ISO 13485, and ISO 14971.
• Ability to complete HIPAA/PHI privacy, general policies and procedures compliance, and security training within the first 30 days and maintain current hirify.global training requirements.

Nice to have

• Hands-on experience with NGS workflows such as DNA extraction and whole-exome or whole-genome library preparation.
• Experience with DNA molecular biology techniques including PCR, qPCR, and multiplex PCR.
• Experience developing and validating molecular assays for IVD and CLIA laboratory testing.

Culture & Benefits

• Cross-functional environment involving statisticians, geneticists, physicians, laboratory scientists, software engineers, and business professionals.
• Medical, dental, vision, life, and disability plans for eligible employees and dependents.
• Free testing for employees and immediate family members, plus fertility care benefits.
• Pregnancy and baby bonding leave, 401(k), commuter benefits, and an employee referral program.
• Inclusive workplace focused on collaboration and improving patient care.