Scientist II, Diagnostic Development & Validation (NGS)

Location: Boston, Massachusetts, US; regular onsite work at a designated hirify.global location is required.

Salary: $127,450–$159,300 per year, with a potential discretionary annual bonus and benefits.

Company

hirify.global is a global, patient-focused precision medicine company delivering diagnostic solutions for cancer and other diseases.

What you will do

• Develop, verify, validate, and optimize novel NGS-based oncology diagnostic assays from concept through commercial launch.
• Prepare and process blood, plasma, FFPE, nucleic acid, and oncology samples using automated workflows and LIMS.
• Design and execute feasibility, development, and validation studies; establish performance parameters and quality controls for critical reagents.
• Analyze experimental data, prepare study reports for regulatory submissions, and maintain QSR-compliant documentation, SOPs, protocols, and reports.
• Lead training and performance qualification during technology transfers and collaborate with molecular biology, computational, QA, and regulatory teams.
• Troubleshoot assay performance, evaluate emerging analytical technologies, and present scientific and technical findings.

Requirements

• Bachelor’s degree in chemical, physical, or biological science or medical technology plus 4+ years of industry experience, or a master’s degree in one of these fields plus 2+ years of industry experience.
• Strong scientific understanding of molecular biology and genomics, including complex molecular biology techniques and NGS workflows such as DNA sequencing, library preparation, and target enrichment.
• Experience developing, implementing, supporting, optimizing, and validating high-complexity clinical assays, including QSR- or CLIA-certified tests.
• Experience writing SOPs, validation plans and protocols, data reports, and QSR-compliant documentation within FDA QSR, CLIA, ISO, or CAP-regulated environments.
• Ability to work with biological specimens, chemicals, and reagents; experience with assay parameters, troubleshooting, optimization, and technical robustness.
• Experience with Hamilton products, robotic liquid handlers, laboratory automation, and instrumentation.
• Excellent technical writing, presentation, oral and written communication, collaboration, problem-solving, prioritization, and organizational skills.
• Demonstrated history of completing individual and collaborative industry projects on time and meeting project deadlines.
• Understanding of HIPAA and the importance of patient data privacy; commitment to FMI’s values of Integrity, Courage, and Passion.

Nice to have

• Master’s degree or PhD in Molecular Biology, Biochemistry, or Genetics.
• 6+ years of commercial science experience in Molecular Biology or Biochemistry.
• Current California Clinical Laboratory Science or Clinical Molecular Biology license.

Culture & Benefits

• Full-time onsite work with attendance policies applying.
• Benefits eligibility and potential discretionary annual bonus based on individual and company performance.
• Opportunities to rotate across projects, broaden skills, and participate in the ENRICH Global Operations rotational program.
• hirify.global supports employee growth and equal employment opportunity.