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.
