Research Scientist II

The Fountain Group; San Diego (CA); On-site; USD 143,270,000 - 151,536,000; Full time

Job summary

The Fountain Group is seeking a Research Scientist Contractor in La Jolla, CA, to lead verification and validation studies for NGS-based multi-cancer early detection tests within a CAP/CLIA clinical laboratory setting.

You will design experiments, perform quantitative data analysis, and generate technical reports to support PMA/IDE submissions, collaborating with biostatistics, regulatory, and quality teams while mentoring junior staff.

Qualifications

• PhD in relevant scientific field preferred.
• Master's with 4+ years of relevant experience acceptable.
• Bachelor's with 6+ years of relevant experience acceptable.

Responsibilities

• Lead verification and validation studies for NGS-based multi-cancer tests.
• Design studies, perform quantitative data analysis, and interpret results.
• Develop protocols and technical reports; support PMA/IDE submissions.

Skills

NGS assay experience

Verification design

Experimental design

Molecular diagnostics

CAP/CLIA operations

Lab management

Regulatory submissions

Protocol development

Data interpretation

QMS compliance

Education

PhD in related field

Master's +4 yrs experience

Bachelor's +6 yrs experience

Job description

Job Description

Job Title: Research Scientist Contractor
Location: La Jolla, CA
Pay Rate: $50–$53/hr
Duration: 3 months / through EOY

Lead verification and validation studies supporting the launch and regulatory submission of NGS-based multi-cancer early detection molecular tests in a CAP/CLIA clinical laboratory environment. Responsibilities include study design and execution, quantitative data analysis, interpretation of experimental results, protocol development, technical reporting, and support for PMA and IDE submissions. Collaborate with biostatistics, bioinformatics, regulatory, medical, quality, and clinical laboratory teams. Provide technical guidance to junior research associates and support laboratory operations and quality management requirements.

Education

• PhD in a relevant scientific field; or
• Master's degree in a related field with 4+ years of relevant experience; or
• Bachelor's degree in a related field with 6+ years of relevant experience.

Required Skills

• NGS-based molecular assay experience
• Verification and validation study design and execution
• Complex experimental design and quantitative data analysis
• Molecular diagnostics and multi-cancer early detection testing
• CAP/CLIA clinical laboratory operations
• Laboratory operations and management
• PMA and IDE regulatory submission support
• Protocol and procedure development
• Scientific data interpretation and technical reporting
• Quality Management System (QMS) compliance

Preferred Skills

• Experience supporting molecular diagnostic product launches
• Experience working with biostatistics and bioinformatics teams
• Experience presenting and defending experimental findings in scientific project reviews
• Experience mentoring junior research scientists or research associates
• Experience with clinical laboratory regulatory and quality requirements