Senior Scientist NGS & Biomarker Validation Lead

ProKatchers LLC; San Diego (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

ProKatchers LLC seeks an experienced Life Sciences professional to lead verification and validation for NGS-based molecular tests in a CAP/CLIA setting. The role supports regulatory submissions (PMA/IDE) and requires extensive hands-on work with NGS workflows from clinical samples.

Candidates should have 8+ years in research and 6+ years in biotech/medical device environments, with strong experience in GMP/ISO processes and genomic data analysis using bioinformatics tools.

Qualifications

• 8+ years of industry or academic research experience in Life Sciences, Chemistry, or related field.
• 6+ years in medical device/IVD, biotech, life science or pharmaceutical industry.
• GMP and/or ISO environment experience preferred.
• Experience with genomic databases and related software.
• Hands-on NGS development, optimization and troubleshooting for DNA/RNA from clinical samples.

Responsibilities

• Lead verification and validation studies to support molecular test launch in a clinical lab.
• Support regulatory submissions, including PMA and IDE processes.
• Collaborate across teams to ensure NGS workflows meet quality and compliance standards.

Skills

NGS

Verification

Validation

Workflows

Computational methods

Epigenomic

Biomarkers

Tools

Genomic databases

Bioinformatics software

Job description

ProKatchers LLC seeks an experienced Life Sciences professional to lead verification and validation for NGS-based molecular tests in a CAP/CLIA setting. The role supports regulatory submissions (PMA/IDE) and requires extensive hands-on work with NGS workflows from clinical samples.

Candidates should have 8+ years in research and 6+ years in biotech/medical device environments, with strong experience in GMP/ISO processes and genomic data analysis using bioinformatics tools.