Director of Clinical Chemistry at SiPhox Health in Burlington, Massachusetts

Job Description:

About SiPhox:

SiPhox, supported by Y Combinator, Intel, and Khosla Ventures, is revolutionizing diagnostics through silicon photonics. Our in-vitro diagnostic (IVD) devices, powered by disposable silicon photonic chip sensors, deliver the capabilities of large laboratory instruments in a compact form. Our mission is to provide accurate, reliable, and accessible diagnostic tools that empower healthcare professionals and improve patient outcomes.

SiPhox is in the middle of an ambitious effort to develop and commercialize a large menu of immunoassay and chemistry targets on its multiplexed clinical-grade, validated, at-home diagnostics platform.

Responsibilities:

Clinical & Laboratory Science

• Provide clinical and technical expertise to the development of IVD assays, including blood and serum-based immunoassays
• Define and evaluate pre-analytical variables (e.g., temperature stability, hemolysis tolerance, anticoagulant effects)
• Manage and oversee the clinical sample repository for assay development and validation.
• Operate and maintain clinical and chemical analyzers
• Design, perform, and interpret clinical laboratory tests related to assay development

Assay Validation & Development

• Design and oversee clinical validation studies to ensure IVD products meet sensitivity, specificity, and reproducibility requirements
• Develop and optimize clinical validation protocols, including statistical analysis and performance criteria
• Work with R&D teams to establish acceptance criteria for assay performance and troubleshoot assay failures

Regulatory & Compliance

• Ensure compliance with FDA, CLIA, and other relevant regulatory standards
• Prepare clinical data and documentation for regulatory submissions (e.g., FDA 510(k), IVDR, CE-IVD)
• Support audits and inspections from regulatory and accreditation bodies

Cross-functional Collaboration

• Work closely with multi disciplinary teams to guide assay development from concept to commercialization
• Lead and mentor others on assay procedures, validation protocols, and troubleshooting
• Communicate findings through technical reports, scientific publications, and presentations

Please note: this is a fully in-person role that requires overtime hours

Qualifications:

Required

• PhD or Master's in Clinical Laboratory Science, Biomedical Science, Biochemistry, Immunology, or a related field
• 7+ years of industry experience in IVD assay development, clinical validation, or clinical laboratory science
• Hands-on experience with clinical and chemical analyzers
• Strong understanding of clinical sample handling, stability requirements, and laboratory best practices
• Previous experience managing clinical sample repositories

Preferred

• Experience working in a CLIA-certified or accredited clinical lab
• Familiarity with statistical analysis software for assay validation (e.g., JMP, R, GraphPad Prism).
• Knowledge of regulatory standards (FDA, CLIA, IVDR, ISO 13485, ISO 15189)
• Experience designing and executing clinical validation studies
• Strong communication skills and ability to collaborate across disciplines

Personal Characteristics:

• Leads by example-drives team enthusiasm-inspires & energizes
• Not afraid to do hands-on work in the lab
• Sets and achieves tough stretch goals; delivers outstanding, measurable results
• Absolute personal integrity and credibility; humble but delivers outsized results
• Passion for excellence in people, processes, and products
• Risk-taker who challenges conventional solutions
• Creative, thinks out of the box; thinks strategically

Benefits:

• Comprehensive benefits package, including LifeTime Fitness gym membership
• Opportunities for professional growth and development
• Work in a dynamic, innovative environment with cutting-edge technology

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