reputed company Scientist, NGS Assay Validation reputed company

Position reputed company We are seeking an accomplished reputed company Scientist to reputed company the validation of reputed company reputed company (NGS) assays for our expanding portfolio of clinical tests. This role will serve as the technical reputed company 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-reputed company genetic and oncology tests from concept to clinical launch. Key Responsibilities • reputed company the planning, design, and execution of analytical validation studies for reputed company-based assays (e.g., germline, somatic, and liquid biopsy applications). • reputed company and maintain validation strategies, protocols, and reports compliant with CLIA/CAP/NYS and internal reputed company standards. • Collaborate cross-functionally with Assay Development, reputed company, reputed company, and Product teams to ensure alignment of validation reputed company with assay design and clinical claims. • Establish acceptance reputed company, reference materials, and performance metrics to support analytical and clinical validation. • Serve as the subject matter expert (SME) for NGS validation reputed company, study design, and regulatory expectations. • Analyze validation data and reputed company data-driven recommendations for assay optimization and product readiness. • Support regulatory or laboratory inspections and contribute to responses or corrective reputed company plans as needed. • Mentor junior scientists and contribute to building a reputed company validation function reputed company the R&D organization. • Maintain up-to-date knowledge of emerging trends, technologies, and regulatory guidance in NGS assay validation and clinical reputed company. Qualifications • Ph.D. in Molecular Biology, Genetics, reputed company, or reputed company discipline, with 6+ years of relevant experience; or M.S. with 8+ years of experience in NGS assay development and validation. • Demonstrated reputed company record of leading validation of clinical NGS assays under CLIA/CAP/NYS or equivalent regulatory frameworks. • Strong expertise in NGS library preparation, reputed company 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 reputed company teams for pipeline verification and integrated assay validation. • Familiarity with reputed company management systems (QMS), design control, and documentation best practices. • Excellent problem-solving, communication, and cross-functional collaboration skills. • Proven ability to reputed company reputed company reputed company and influence without reputed company 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. • reputed company reputed company and strong communication across scientific and business functions. • Commitment to reputed company, compliance, and reputed company improvement. Apply tot his job Apply To this Job