Senior Scientist

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

Specific Skills : NGS, verification, validation, workflows, computational methods, epigenomic, biomarkers

Job Description:

• Lead select verification and validation studies to support molecular test product launch in CAP/CLIA clinical laboratory and regulatory submission, including but not limited to: PMA (Pre-market approval) and IDE (Investigational Device Exemption)
• 8+ years of industry or academic research experience in Life Sciences, Chemistry, or related field.
• 6+ years of experience in medical device/IVD, biotech, life science or pharmaceutical industry.
• Experience in a pharmaceutical or biotech manufacturing environment, preferably in a GMP and/or ISO environment.
• Experience with genomic databases and related software.
• Deep understanding of the practices and principles of NGS including molecular biology and data analysis based upon extensive hands-on experience with the development, optimization and troubleshooting of NGS-based workflows for DNA and RNA from clinical samples.
• Extensive experience with interpretation and analysis of NGS data using external and in-house computational methods to support method development and characterization of genomic and epigenomic biomarkers associated with cancer.