Principal Scientist, NGS Assay Validation Lead

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 • Ph.D. in Molecular Biology, Genetics, Genomics, or related discipline, with 6+ years of relevant experience; or M.S. with 8+ years of experience in NGS assay development and validation. • Demonstrated track record of leading validation of clinical NGS assays under CLIA/CAP/NYS or equivalent regulatory frameworks. • Strong expertise in NGS library preparation, sequencing platforms, and assay performance characterization. • Deep understanding of analytical validation parameters (accuracy, precision, LoD, specificity, reproducibility, etc.) and their statistical evaluation. • Experience collaborating closely with bioinformatics teams for pipeline verification and integrated assay validation. • Familiarity with quality management systems (QMS), design control, and documentation best practices. • Excellent problem-solving, communication, and cross-functional collaboration skills. • Proven ability to lead complex projects and influence without direct authority in a matrixed environment. Preferred Qualifications • Prior experience with oncology and germline clinical genetic testing. • Knowledge of NYS clinical test submission or FDA IVD development processes. • Experience managing or mentoring junior scientists. • Familiarity with automation or process scaling for NGS workflows. Key Attributes • Scientific rigor and attention to detail. • Strategic thinking with hands-on execution capability. • Collaborative mindset and strong communication across scientific and business functions. • Commitment to quality, compliance, and continuous improvement. Apply tot his job