Senior Assay Development Consultant / Contractor POC IVD Clinical Chemistry

Location: Monmouth Junction, New Jersey 08852. On-site preferred; part-time / project-based consulting arrangement.

Employment Type: Consultant / Contractor / Part-Time / Hybrid.

Position Summary: 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. This role is intended for a consultant with strong hands‑on experience developing biochemical or clinical chemistry assays that can be translated into manufacturable IVD products, especially assays using dry reagent formats, lyophilized reagent beads, or stabilized reagent systems. The consultant will help design, optimize, troubleshoot, and productize assays for analyzer-based POC diagnostic systems. Prior experience with Lab-on-Disk, Lab-on-Spin-Disk, cartridge-based clinical chemistry platforms, or similar POC IVD systems is highly preferred. Target Assay Areasglucosealbumincreatininelipid paneltriglyceridescholesterolmetabolic panelelectrolyte panelliver function markers such as AST and

ALTKey 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.

Required Qualifications: 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. Ability to work independently as a senior technical consultant while collaborating with cross‑functional teams.

Preferred 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.

Ideal Candidate Profile: The ideal candidate is not only a strong assay scientist, but someone who has previously helped bring clinical chemistry assays into real diagnostic products. We are especially interested in candidates who understand the practical challenges of converting liquid reagent chemistry into stable dry or lyophilized formats for POC platforms. The candidate should be able to provide senior‑level technical direction, quickly diagnose assay development bottlenecks, and help the internal team accelerate development toward a manufacturable and commercially viable product. Soft Skills Strong hands‑on problem‑solving ability in assay development. Practical understanding of product development, not only academic assay design. Strong experimental rigor and attention to detail. Ability to communicate technical findings clearly to scientific, engineering, and business teams. Comfortable working in a fast‑paced startup/product development environment. Able to work independently with limited supervision. Collaborative mindset across assay, engineering, manufacturing, QA/QC, and regulatory functions.

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.