Director, R&D (Assay Development)

TL;DR

Director, R&D (Assay Development): Leading the development, optimization, and validation of diagnostic assays for a clinical laboratory portfolio with an accent on CAP/CLIA compliance and high-throughput instrumentation. Focus on scaling the R&D function through hands-on leadership, establishing validation protocols, and driving innovation in at-home testing workflows.

Location: Must be based in South Plainfield, New Jersey (On-site)

Salary: $185,000 – $205,000

Company

hirify.global is a leading health and wellness platform dedicated to making personalized healthcare affordable and accessible through an innovative, customer-first model.

What you will do

• Lead the development and validation of diagnostic assays across the testing portfolio.
• Design verification studies in strict alignment with CAP/CLIA requirements.
• Build and mentor a high-performing team of scientists and research associates.
• Operate hands-on in the lab to execute experiments, analyze data, and troubleshoot workflows.
• Partner with Regulatory and Quality teams to ensure compliance and audit readiness.
• Develop technical documentation, validation reports, and SOPs for laboratory processes.

Requirements

• PhD in Clinical Chemistry, Biochemistry, Molecular Biology, Immunology, or a related field.
• Minimum 5 years of experience in diagnostic assay development within a clinical laboratory environment.
• Deep expertise with Roche Cobas Pro and Sysmex instrumentation.
• Strong statistical knowledge applied to method validation and experimental design.
• Demonstrated success in leading complex R&D initiatives and scaling technical teams.
• Proven ability to perform hands-on bench work and direct experimental data analysis.

Culture & Benefits

• Comprehensive health benefits including medical, dental, and vision coverage.
• Competitive equity compensation and Employee Stock Purchase Program (ESPP).
• 401k plan with employer matching.
• Unlimited PTO plus company holidays and quarterly mental health days.
• Supportive environment focused on diverse perspectives and employee wellness.