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ClearNote Health · 1 month ago

Sr. Scientist Product Development

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$145K/yr - $180K/yr

3+ years exp

ClearNote Health is seeking a highly skilled Senior Scientist in Product Development with expertise in Molecular Diagnostics to lead the development and optimization of cutting-edge molecular assays for early cancer detection. The successful candidate will be responsible for assay development, verification, validation, and regulatory submissions, collaborating closely with various departments to ensure compliance and efficiency.

BiotechnologyClinical TrialsHealth CareTest and Measurement

H1B Sponsor Likely

Responsibilities

Lead the design, development, and optimization of molecular diagnostic assays (e.g., NGS)

Evaluate and optimize sample preparation, extraction, and amplification methodologies

Conduct feasibility studies and proof-of-concept experiments

Develop robust, reproducible, and scalable workflows for diagnostic applications

Execute verification and validation (V&V) studies in accordance with regulatory and industry standards (e.g., FDA, IVDR, CLIA)

Analyze data, troubleshoot assay performance issues, and implement solutions

Contribute to development of target product profiles

Ensure development activities comply with FDA, CLIA, CAP, IVDR, and ISO 13485 requirements

Author and review technical documents, study protocols, and reports for regulatory submissions

Partner with quality and regulatory teams to support product approvals and audits

Work closely with research department, bioinformatics, engineering, and laboratory operations

Engage with external partners, KOLs, and industry stakeholders

Qualification

Molecular DiagnosticsNGSRegulatory ComplianceLaboratory AutomationProject LeadershipCross-Functional CollaborationTechnical Documentation

Required

Deep knowledge of molecular technologies, such as NGS, RNA-Seq, qPCR, ddPCR, and epigenomic assays

Minimum 2 years of supervisory or project leadership experience

Experience with laboratory automation and workflow integration

Ability to evaluate vendors, technologies, and assays for commercial feasibility

Ph.D. in Molecular Biology, Biochemistry, Genetics, or related field with 3 - 5+ years of industry experience, or

M.S. with 6+ years of relevant experience in molecular diagnostics product development

Company

ClearNote Health

ClearNote Health is a cancer detection company.

Founded in 2016

San Mateo, California, USA

11-50 employees

https://www.clearnotehealth.com

H1B Sponsorship

ClearNote Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (2)