Part Time Remote Assay Development Scientist

Location: Cranbury

Job Title:

Assay Development Scientist

Job Description

Join a fast-growing medical device company dedicated to advancing point-of-care diagnostic platforms for decentralized clinical testing. Our innovative technologies integrate microfluidics, precision instrumentation, imaging, automation, and scalable manufacturing to deliver accessible, high-quality diagnostics worldwide. We are expanding our U.S.

-based assay development capabilities and advancing next-generation diagnostic platforms from feasibility to 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 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 instrumentation.

+ Collaborate 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.

Essential Skills

+ Hands-on experience with Lab-on-Spin-Disk or similar centrifugal microfluidic IVD chemistry diagnostic platforms.

+ Strong knowledge in clinical chemistry/biochemistry assay development, particularly enzymatic, colorimetric, or spectrophotometric assays.

+ Experience developing lyophilized reagent beads or dry/stabilized reagent formats.

+ 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 or analyzer-based systems.

+ Solid understanding of enzymatic assays, colorimetric/spectrophotometric assays, clinical chemistry principles, and reagent formulation.

Additional

Skills & Qualifications

+ Direct experience with Lab-on-Spin-Disk, Lab-on-Disk, 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, and precision studies.

Work Environment

The work environment includes a standard office setting as well as laboratory and manufacturing production environments. Training in controlled clean environments is necessary due to exposure to potentially hazardous materials and equipment. Appropriate gowning and safety rules apply, including the use of lab coats, safety glasses, and gloves. Reasonable accommodations are provided to support individuals with disabilities. The company maintains a commitment to equal opportunity employment.

Job Type & Location

This is a Contract position based out of Cranbury, NJ.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on…