Senior Assay Development Consultant / Contractor POC IVD Clinical Chemistry

About the role

We are seeking an experienced POC IVD Assay Development Consultant / Contractor to support and accelerate the development of clinical chemistry assays for a Lab-on-Spin-Disk / centrifugal microfluidic diagnostic platform.

Responsibilities

• Develop, optimize, and troubleshoot biochemical and clinical chemistry assays for POC IVD platforms.
• Support assay development on Lab-on-Spin-Disk, Lab-on-Disk, centrifugal microfluidic, or equivalent cartridge/analyzer-based systems.
• Design and optimize reagent formulations, including enzyme systems, buffers, calibrators, stabilizers, surfactants, preservatives, and dry reagent formats.
• Develop or improve lyophilized reagent bead formulations suitable for product integration and manufacturing transfer.
• Evaluate assay performance, including precision, accuracy, linearity, sensitivity, specificity, reportable range, interference, and matrix effects.
• Conduct method comparison studies against reference analyzers or established clinical chemistry systems.
• Support real-time and accelerated stability studies for liquid, dried, and lyophilized reagent formats.
• Troubleshoot assay performance issues related to reagent chemistry, sample matrix, disk/cartridge design, fluidics, optical detection, and instrument interaction.
• Work closely with engineering, instrumentation, software, manufacturing, QA/QC, and regulatory teams to ensure assay-platform compatibility.
• Provide technical guidance to accelerate assay development from feasibility to product-ready design.
• Support transfer of assays from R&D to manufacturing and quality control.

Requirements

• PhD in Biochemistry, Analytical Chemistry, Clinical Chemistry, Chemistry, Biomedical Engineering, or a related field; or MS/BS with significant relevant industry experience.
• 5+ years of hands-on IVD assay development experience, preferably in POC diagnostics, clinical chemistry, or analyzer-based system.
• Strong experience developing assays for automated analyzers, cartridge-based systems, Lab-on-Disk platforms, or similar diagnostic platforms.
• Solid understanding of enzymatic assays, colorimetric/spectrophotometric assays, clinical chemistry principles, and reagent formulation.
• Experience translating assays from feasibility into robust product development.
• Experience with assay verification, validation, performance characterization, and troubleshooting.
• Proven ability to identify root causes of assay failure and improve assay robustness.
• Able to work independently as a senior technical consultant while collaborating with cross-functional teams.

Qualifications

• Direct experience with Lab-on-Spin-Disk, Lab-on-Disk, centrifugal microfluidics, or similar POC diagnostic platforms.
• Experience developing multi-analyte clinical chemistry panels.
• Experience with dry chemistry, lyophilized reagent beads, reagent stabilization, or dry reagent manufacturing for IVD applications.
• Experience with clinical chemistry panels such as glucose, albumin, creatinine, lipid panel, metabolic panel, electrolyte panel, liver panel, AST, ALT, and related assays.
• Experience with product commercialization, design transfer, or regulatory submissions for IVD products.
• Familiarity with statistical tools for assay evaluation, including regression analysis, correlation studies, Bland–Altman analysis, precision studies, and method comparison.
• Prior experience at diagnostics companies such as Abaxis, Abbott, Roche Diagnostics, Siemens Healthineers, Beckman Coulter, Ortho Clinical Diagnostics, or similar companies.

Preferred Qualifications

• Experience with clinical chemistry panels such as glucose, albumin, creatinine, lipid panel, metabolic panel, electrolyte panel, liver panel, AST, ALT, and related assays.
• Experience with product commercialization, design transfer, or regulatory submissions for IVD products.
• Familiarity with statistical tools for assay evaluation, including regression analysis, correlation studies, Bland–Altman analysis, precision studies, and method comparison.
• Prior experience at diagnostics companies such as Abaxis, Abbott, Roche Diagnostics, Siemens Healthineers, Beckman Coulter, Ortho Clinical Diagnostics, or similar companies.

What We Offer

• Flexible consulting / contractor arrangement.
• Competitive hourly or project-based compensation.
• Opportunity to contribute directly to commercial POC IVD product development.
• Hands-on involvement in next-generation Lab-on-Spin-Disk diagnostic platform development.
• Collaborative cross-functional R&D environment.
• Opportunity for technical leadership and potential longer-term collaboration.

How To Apply

Please submit your resume and a brief summary of your relevant experience in POC IVD assay development, clinical chemistry assay development, Lab-on-Disk/Lab-on-Spin-Disk systems, or lyophilized reagent bead development.