Principal Scientist, NGS Assay Validation Lead

Job Description

Job Description

Position Summary

We are seeking an accomplished Principal Scientist to lead the validation of next-generation sequencing (NGS) assays for our expanding portfolio of clinical tests. This role will serve as the technical lead for end-to-end wet-lab assay validation, ensuring robust analytical and clinical performance for assays developed under CLIA / CAP / NYS regulatory frameworks.

The ideal candidate will combine deep technical expertise in NGS assay development with a strategic understanding of clinical diagnostics, playing a pivotal role in advancing high-quality genetic and oncology tests from concept to clinical launch.

Key Responsibilities

• Lead the planning, design, and execution of analytical validation studies for sequencing-based assays (e.g., germline, somatic, and liquid biopsy applications).
• Develop and maintain validation strategies, protocols, and reports compliant with CLIA / CAP / NYS and internal quality standards.
• Collaborate cross-functionally with Assay Development, Bioinformatics, Quality, and Product teams to ensure alignment of validation strategy with assay design and clinical claims.
• Establish acceptance criteria, reference materials, and performance metrics to support analytical and clinical validation.
• Serve as the subject matter expert (SME) for NGS validation methods, study design, and regulatory expectations.
• Analyze validation data and provide data-driven recommendations for assay optimization and product readiness.
• Support regulatory or laboratory inspections and contribute to responses or corrective action plans as needed.
• Mentor junior scientists and contribute to building a scalable validation function within the R&D organization.
• Maintain up-to-date knowledge of emerging trends, technologies, and regulatory guidance in NGS assay validation and clinical genomics.

Qualifications

Preferred Qualifications

Key Attributes