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”

MagArray, Inc. 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. Our CLIA laboratory incorporates this technology in the REVEAL test for lung nodule characterization. MagArray 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 Clinical Laboratory Scientist to join our team. In this position, you will be the lead CLS in our existing CLIA laboratory and work together with our R&D and Life Sciences services teams on the development and introduction of new tests and services. You will play an integral role in a dynamic, multidisciplinary, matrixed team environment.

The Clinical Laboratory Scientist is responsible for all patient testing and related quality procedures including, but not limited to, specimen processing, test performance and reporting test results.

The ideal candidate will have experience in the operation of state-of-the-art immunoassays, expert knowledge of regulatory requirements, and excellent analytical skills.

Reporting Relationships: Reports to the Technical Supervisor and is directly accountable to the Laboratory Director.

Responsibilities and Duties

  • Independently performs moderate and highly complex clinical tests and accurately enters results
  • Prepares and tests new reagents or controls and evaluates their usefulness; monitors and maintains their supply
  • Performs test calibrations and runs Quality Control materials
  • Evaluates the acceptability of routine analysis prior to releasing patient reports
  • Accurately performs and records proficiency testing
  • Initiates troubleshooting steps to evaluate testing failures
  • Provides on-going technical guidance to Laboratory Assistants
  • Instructs new employees on laboratory procedures
  • Maintains professional growth through continuing education
  • Responsible for performing daily/general/preventative maintenance and/or calibration of laboratory equipment
  • Responsible for accurate documentation and maintaining records, especially as it relates to the CLIA laboratory
  • Responsible for reporting all problems to a general supervisor as required
  • Demonstrates high level of integrity and honesty in maintaining compliance with HIPAA regulations
  • Follows all laboratory policies and procedures including, but not limited to, general processes, safety and quality
  • Sets up, performs and reports test analysis results for moderate and high complexity tests
  • Gathers P/M and QC data for supervisors to OK prior release of any patient’s results
  • Closely monitors controls and QC material performance data
  • Knowledgeable in all “Out of Control Protocols”
  • Prepares orders and maintains reagents and supplies as required
  • Prioritizes tasks and duties consistent with the CLIA laboratory goals
  • Properly escalates issues to, and effectively communicates with, the Supervisor
  • Experience in test validation, technical transfers, as well as authoring procedures and QC documents
  • Participates in special projects and product development including product transfer into the CLIA lab

Qualifications and Skills

  • Must have a bachelor’s degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution, or the equivalent
  • Must hold a current State of California license in Medical Technology/Clinical Laboratory Science. If candidate holds a limited license, it must be a Clinical Chemistry sub-specialty
  • Minimum of 1 year of laboratory training and/or experience in high complexity testing
  • Preferred at least 1 year of supervisory experience in a CLIA-certified lab
  • Demonstrated proficiency in patient testing, quality control, quality assurance, project management, and analysis of results
  • Sufficient knowledge and understanding of laboratory operations and their relationship to the organization to solve testing, quality, and customer service issues
  • Knowledge of CLIA regulations and CAP guidelines
  • Must have excellent interpersonal and language skills to communicate proactively with physicians, customers, and colleagues
  • Highly detail oriented, analytical, and a problem-solver
  • Collaborative, reliable, cooperative, flexible, and other skills of an effective team player
  • Proficient in Microsoft Office programs (i.e. Word, Excel, PowerPoint)

Physical Requirements

The Clinical Laboratory 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 their 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: “Clinical Laboratory Scientist, CLIA Lab”