Associate Director, Assay Validation (NGS)

Location: United States remote or Houston, TX; work may take place in an office, remotely, and/or in a laboratory depending on business needs and assigned responsibilities.

Company

hirify.global develops and supports clinical genomics and genetic testing services.

What you will do

• Lead the planning, design, and execution of analytical validation studies for sequencing-based germline, somatic, and liquid biopsy assays.
• Develop validation strategies, protocols, reports, acceptance criteria, reference materials, and performance metrics.
• Partner with Assay Development, Bioinformatics, Quality, and Product teams to align validation with assay design, clinical claims, and product readiness.
• Analyze validation data and recommend assay optimization, issue resolution, and launch-readiness actions.
• Support regulatory and laboratory inspections, responses, documentation, and corrective action plans.
• Mentor scientists and help build a scalable validation function within R&D.

Requirements

• PhD in Molecular Biology, Genetics, Genomics, or a related discipline with 6+ years of relevant experience, or an M.S. with 8+ years of experience in NGS assay development and validation.
• Experience leading validation of clinical NGS assays under CLIA, CAP, NYS, or equivalent regulatory frameworks.
• Strong expertise in NGS library preparation, sequencing platforms, assay performance characterization, and analytical validation parameters.
• Experience collaborating with bioinformatics teams on pipeline verification and integrated assay validation.
• Familiarity with quality management systems, design control, and documentation practices.
• Ability to lead complex projects, influence without direct authority, and collaborate across a matrixed organization.

Nice to have

• Experience with germline clinical genetic testing or prenatal liquid biopsy testing.
• Knowledge of NYS clinical test submission requirements or FDA IVD development processes.
• Experience managing a small team.
• Familiarity with automation or process scaling for NGS workflows.

Culture & Benefits

• Work may be performed in office, remote, and laboratory environments based on business needs.
• Responsibilities require adherence to applicable safety, quality, regulatory, and company requirements.
• Travel requirements may vary based on business needs.
• Equal opportunity workplace committed to an inclusive and diverse environment.