Senior Scientist, Molecular Assay Development in R&D

Location: Chicago, Illinois, United States

Salary: $94,000–$135,000 per year for roles performed from Illinois; compensation may vary for California, Colorado, and New York.

Company

hirify.global develops a precision medicine platform that uses AI and real-world evidence to provide actionable insights for clinical care.

What you will do

• Co-lead the design and development of molecular assays supporting IVD and CDx programs.
• Provide scientific and technical leadership to cross-functional teams, including technology development, bioinformatics, quality control, regulatory affairs, and clinical laboratory groups.
• Lead validation projects from inception through launch, including sample selection, laboratory validation, workflow and SOP development, and validation plans and summaries.
• Design assay performance specifications and manage R&D design documentation.
• Troubleshoot technical issues, track project milestones and budgets, and respond to changing priorities.
• Maintain compliant laboratory procedures and improve the efficiency, quality, and effectiveness of R&D activities.

Requirements

• PhD in Nucleic Acids Biochemistry, Molecular Biology, or a related field with 3+ years of industry experience, or an MS with commensurate industry experience.
• Leadership experience in assay development for IVD products in an FDA-regulated environment under design controls.
• Hands-on expertise with nucleic acid technologies, preferably including NGS, PCR, and qPCR.
• Ability to apply quality control and quality assurance principles to development activities.
• Strong understanding of FDA, EUA, and other global regulatory requirements.
• Strong technical and project leadership, organization, attention to detail, and ability to work in a fast-paced, team-driven environment.

Culture & Benefits

• Full-time employment.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other benefits depending on the position.