Assay Development Scientist

Location: Monmouth Junction

Job Title:

Assay Development Scientist (POC IVD Consultant / Contractor)

Job Description

This consulting role supports a fast-growing medical device organization that develops innovative point-of-care diagnostic platforms for decentralized clinical testing. The Assay Development Scientist will lead the design, optimization, and productization of clinical chemistry assays for a Lab-on-Spin-Disk / centrifugal microfluidic diagnostic platform, translating assays from feasibility to robust, manufacturable in vitro diagnostic products. The position focuses on dry and stabilized reagent formats, including lyophilized reagent beads, and involves close collaboration with cross-functional teams to advance next-generation point-of-care diagnostics from concept through commercialization.

Responsibilities

+ Develop, optimize, and troubleshoot biochemical and clinical chemistry assays for point-of-care in vitro diagnostic 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 that are suitable for integration into products and transfer to manufacturing.

+ Evaluate assay performance parameters such as precision, accuracy, linearity, sensitivity, specificity, reportable range, interference, and matrix effects.

+ Conduct method comparison studies against reference analyzers or established clinical chemistry systems to demonstrate equivalence or superiority.

+ 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 or cartridge design, fluidics, optical detection, and instrument behavior.

+ Work closely with engineering, instrumentation, software, manufacturing, quality assurance, quality control, and regulatory teams to ensure assay and platform compatibility.

+ Provide senior-level technical guidance to accelerate assay development from feasibility through product-ready design.

+ Support the transfer of assays from research and development into manufacturing and quality control processes.

+ Contribute to the development of multi-analyte clinical chemistry panels, including glucose, albumin, creatinine, lipid panels, metabolic panels, electrolyte panels, and liver function markers such as AST and ALT.

+ Apply statistical tools and structured experimental design to evaluate assay performance, interpret data, and drive optimization decisions.

+ Document development activities, protocols, and results in a clear and compliant manner to support design transfer and potential regulatory submissions.

Essential Skills

+ 5+ years of hands-on in vitro diagnostic assay development experience, preferably in point-of-care diagnostics, clinical chemistry, or analyzer-based systems.

+ Proven track record taking assays beyond feasibility into product-ready or manufacturable point-of-care IVD formats, not limited to academic research.

+ Hands-on experience with Lab-on-Spin-Disk, centrifugal microfluidic IVD chemistry diagnostic platforms, or closely related cartridge/analyzer-based systems.

+ Strong background in clinical chemistry and biochemistry assay development, particularly enzymatic and colorimetric/spectrophotometric assays for analytes such as glucose, albumin, creatinine, BUN, AST, ALT, ALP, sodium, potassium, triglycerides, and cholesterol.

+ Solid understanding of protein, enzyme, and antibody structure, function, and interactions as they relate to assay performance and stability.

+ Hands-on experience developing lyophilized reagent beads or dry/stabilized reagent formats, including formulation, optimization, stability assessment, troubleshooting, and progression toward manufacturing.

+ Strong experience developing assays for automated analyzers, cartridge-based systems, Lab-on-Disk platforms, or similar diagnostic platforms.

+ Deep knowledge of enzymatic and colorimetric/spectrophotometric assays, clinical chemistry principles, and reagent formulation strategies.

+ Experience translating assays from feasibility into robust product-ready designs suitable for manufacturing and commercialization.

+

Experience with assay verification, validation, performance characterization, and systematic troubleshooting.

+ Demonstrated ability to identify root causes of assay failure and implement solutions to improve robustness and reliability.

+ Ability to work independently as a senior technical consultant while effectively collaborating with cross-functional teams.

Additional

Skills & Qualifications

+ PhD in Biochemistry, Analytical Chemistry, Clinical Chemistry, Chemistry, Biomedical Engineering, or a related field; or MS/BS with significant relevant industry experience.

+ Direct experience with Lab-on-Spin-Disk, Lab-on-Disk,…