Sr. Scientist-Assay Development

Job Description

TITLE: Sr. Scientist-Assay Development
DEPARTMENT: Assay Development
REPORTS TO: VP Assay Development

Position Summary

Lead the development and performance of directed research in new assays on Genalyte’s instrument platform.

Principal Responsibilities

Responsibilities may include but will not be limited to the following as assigned:

  • Lead, supervise and work with associate scientists in their daily operations and research in diverse biological areas
  • Develop and validate a menu of diagnostic immunoassays on Genalyte’s proprietary technology for regulatory submissions
  • Design and perform research experiments to develop assays using DOE principles in conformance with design control regulations
  • Perform assay optimization, troubleshooting, and transfer of technology to manufacturing and QC
  • Develop QC tests for in-process, final assay reagents, and finished device
  • Perform verification and validation studies for the developed diagnostic assays
  • Contact commercial vendors for sourcing and supplying of specific assay reagents and samples
  • Exercise extensive experience to independently design and execute complex experiments
  • Demonstrate a wide degree of creativity and latitude
  • Analyze and interpret large amounts of instrument data
  • Adhere to a high standard of scientific method
  • Prepare technical reports, summaries, protocols, quantitative analyses and SOPs
  • Act as a source of technical knowledge in a variety of field concepts and procedures
  • Rely on own experience and judgment to plan and accomplish goals
  • Keep detailed lab notebook
  • Perform other duties as assigned by supervisor
  • Maintain compliance with all company policies, quality systems, and procedures

Essential Requirements

  • PhD. in Life Sciences and minimum 6 years of experience or MS with 8+ years of experience in RUO/IVD assay development
  • Demonstrates comprehensive knowledge and experience in immunoassay development
  • Experience in diagnostic assay development in the medical device industry preferred
  • Knowledge/experience in working under ISO13485 and FDA regulations
  • Previous demonstrated ability to exercise a wide degree of creativity and latitude
  • Excellent organizational skills, communication skills, a proactive attitude and the ability to work in fast pace environment
To apply please e-mail Cover Letter and CV to careers@genalyte.com.
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