Principal Scientist, NGS Assay Validation Lead

3 days ago

Houston, Texas, United States Baylor Genetics Full time $120,000 - $180,000 per year

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.

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