Senior Genomics Validation Lead — Data Quality & Compliance

myDNA, Inc.; Houston (TX); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical & Health Savings (Employer HSA

Dental & Vision fully covered

401(k) matching

Diverse PTO framework

Disability & Paid Family Leave

Job summary

Gene by Gene seeks a Senior Validations Specialist to analyze genetic data and validate assays, pipelines, and data systems. You will work with large genomic datasets, implement QC measures, and contribute to software development to solve genomic problems. Applicants should have 4–7 years in bioinformatics or regulatory validation, Ph.D.

or M.S. in a related field, and strong knowledge of QC, regulatory standards, and documentation practices.

Qualifications

• Strong knowledge of bioinformatics tools, pipelines, software, and databases used in genomics (e.g., NGS and genotyping workflows) with Linux/UNIX proficiency.
• Working knowledge of molecular biology and genetic laboratory testing workflows.
• Proficiency in computational and statistical methods for large-scale data analysis.
• Knowledge of quality control, validation/verification, and regulatory standards (CLIA, CAP, ISO, UKAS, etc.).
• Experience drafting validation plans, summary reports, and SOPs in regulated labs.
• Clear written and verbal communication with strong documentation habits.
• Urgency and solutions-focused mindset in a fast-moving environment.

Responsibilities

• Design, execute, and document validation/verification studies for assays and pipelines per regulatory requirements.
• Define acceptance criteria, analyze validation data, and prepare validation reports.
• Drive validation activities to completion, removing roadblocks and updating stakeholders.

Skills

Bioinformatics tools

Genomics data analysis

Linux/UNIX

Molecular biology workflows

Statistical methods

Documentation habits

Urgency mindset

Education

Ph.D. or M.S. in Genetics/ Bioinformatics/ Computational Biology

Tools

Bioinformatics software pipelines

Job description

Gene by Gene seeks a Senior Validations Specialist to analyze genetic data and validate assays, pipelines, and data systems. You will work with large genomic datasets, implement QC measures, and contribute to software development to solve genomic problems. Applicants should have 4–7 years in bioinformatics or regulatory validation, Ph.D.

or M.S. in a related field, and strong knowledge of QC, regulatory standards, and documentation practices.