MagArray, Inc. seeks an Assay Development Scientist to join our growing medical diagnostics team. We develop novel clinical assays based on our revolutionary ultra-sensitive, multiplex immunoassay technology. Originating from Stanford University, the MagArray core technology brings new levels of sensitivity and ease of use to immunoassays through the innovative application of magnetic nanotags and giant magnetoresistance (GMR) sensors. This exciting technology combines traditional immunoassay development with integrated circuit design and nanofabrication. The company is backed by stable funding and is entering a period of accelerated growth to launch diagnostic tests and services.

We are looking for an outstanding individual to join our biomarker team as an Assay Development Scientist. The ideal candidate will have experience in the development of state-of-the-art immunoassays and will work closely with life sciences team members to design, evaluate, optimize, validate and implement biomarker assays

Responsibilities and Duties:

  • Take ownership of assay development projects on the MagArray platform
  • Optimize assay design and reagent formulations to achieve desired levels of performance and stability
  • Develop and implement complex immunoassays using biological fluids in a GLP environment
  • Characterize assay performance across various analytical metrics including accuracy, reproducibility, specificity, sensitivity, linearity, LOD, LLOQ, interference, and other analytical parameters
  • Maintain high standards of laboratory safety and perform research in compliance with all applicable regulatory guidelines
  • Assist in the preparation of protocols and reports in accord with typical Design Control processes
  • Independently execute and deliver high-quality results in a timely manner
  • Keep abreast of relevant literature and attend scientific meetings
  • Prepare, contribute and communicate technical reports, publications, oral presentations, and conference posters
  • Present data at company meetings and to outside customers
  • Coordinate and network with multiple collaborators
  • Coordinate in a matrix environment with other colleagues (research associates, technicians, or engineers) to accomplish the project goals within a larger development effort
  • Interact with other line functions in the company such as Quality Assurance, Regulatory Affairs, Clinical Affairs, Operations, Product Support, Engineering, or Marketing

Qualifications and Skills:

  • PhD in Biological Sciences (molecular biology, immunology, biochemistry, bioengineering, biotechnology, biophysics, or related field), or equivalent combination of M.S./B.S plus experience
  • 2+(PhD) or 8+(MS) or 10+(BS) years of relevant hands-on experience in the assay development environment, preferably developing and supporting quantitative IVD’s and/or LDT’s
  • Experience with experimental design and development of high-throughput, multiplex immunoassays
  • Previous experience with microarray, ELISA, bead-based assays and analysis of fluid biomarkers in clinical samples
  • Experience with surface chemistry related to biosensors or protein modification is a plus
  • Previous experience with assay development on clinical analyzer platforms is preferred
  • Good understanding of regulatory requirements relevant to biomarker development (CLSI guidelines, FDA requirements, ICH GCP standards, etc.)
  • Strong analytical skills in the areas of statistics, Design of Experimentation (DOE), non-linear fitting is desired
  • Familiarity with commonly used office productivity software (Microsoft Office Suite) as well as
    mathematical analysis/statistics and literature search tools
  • Ability to handle multiple tasks and short-notice deadlines, reprioritizing work plans
  • Excellent written and verbal communication skills, flexibility, and willingness to learn new techniques and methods
  • Meticulous attention to detail
  • Strong record keeping skills

Physical Requirements:

The Assay Development Scientist position requires an ability to frequently sit or stand and to talk and hear. The position involves spending extensive time at a lab bench and at computer terminals setting up assays, analyzing data, and preparing reports, summaries, and presentations. Frequently, the employee will be required to use hands to pipette precisely, handle small device components, reach with hands and arms, climb stairs, and occasionally handle heavy jars/totes and gas cylinders. Vision abilities required include close vision, depth perception and ability to adjust focus. For more information or to apply, send an email to careers@magarray.com with the subject line: “Assay Development Scientist”