Assay Development Scientist

Job Description

Job Description

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.

• 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.

• 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, centrifugal microfluidics, or similar point-of-care diagnostic platforms.
• Experience developing multi-analyte clinical chemistry panels for point-of-care or analyzer-based systems.
• 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 panels, metabolic panels, electrolyte panels, liver panels, 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 approaches.
• Familiarity with GMP principles and quality systems as they apply to bioassay and IVD development.
• Prior experience in diagnostics organizations developing analyzer-based or cartridge-based clinical chemistry systems is beneficial.

The role operates within a mixed office, laboratory, and manufacturing production environment in a controlled facility. Work includes time in a standard office setting for data analysis, documentation, and cross-functional collaboration, as well as extensive work in laboratory and production areas. The laboratory and production facilities are controlled clean environments that require appropriate training and adherence to safety and quality procedures. Team members may encounter potentially hazardous materials and equipment, including chemical reagents, donor blood, and automated assembly equipment. In these environments, appropriate gowning and safety practices apply, including the use of lab coats, safety glasses, gloves, and other protective equipment as required for specific activities and procedures. The organization follows equal opportunity principles and provides reasonable accommodations to enable individuals with disabilities to perform the essential functions of the role.

Job Type & Location

This is a Contract position based out of Monmouth Junction, NJ.

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

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Monmouth Junction,NJ.

This position is anticipated to close on Jun 19, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.