Baylor Genetics
Principal Scientist, NGS Assay Validation Lead
Baylor Genetics, Houston, Texas, United States, 77246
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. 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. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Referrals increase your chances of interviewing at Baylor Genetics by 2x Get notified about new Validation Scientist jobs in Houston, TX.
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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. 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. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Referrals increase your chances of interviewing at Baylor Genetics by 2x Get notified about new Validation Scientist jobs in Houston, TX.
#J-18808-Ljbffr