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Assay Development Scientist

MagArray, Inc. – Milpitas, CA

Job Summary

MagArray is a groundbreaking company that is pushing the boundaries of ultrasensitive 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 seeking an experienced and outstanding Immunologist to join our fast-paced research team. In this position, you will work in a dynamic, multidisciplinary, matrixed team environment and will lead teams that generate and summarize data from preclinical and clinical studies. You will work internally and externally with collaborators in designing experiments to advance biomarker efforts that impact clinical and commercial development. Experience in the analysis of data sets, and immune cascades in disease processes will be valuable.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • 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
  • 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:

  • PhD in Biological Sciences (molecular biology, immunology, biochemistry, bioengineering, biotechnology, biophysics, or related field), with at least 2 years of relevant hands-on experience in the assay development environment, preferably developing and supporting quantitative IVDs and/or LDTs
  • Experience with experimental design and development of high-throughput, multiplex immunoassays
  • Previous experience with Luminex, Quanterix, Singulex, ELISA 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
  • Excellent interpersonal communication, organizational and leadership skills with the ability to work independently and in a fast-paced team environment
  • Meticulous attention to detail
  • Strong record keeping skills

PLUSES:

  • Biotechnology or pharmaceutical industry experience
  • Experience managing and developing people
  • Experience leading a cross-disciplinary project team

Job Type: Full-time

Work Location:

  • One location

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