o Plan and implement the immunoassay, hardware, software, and/or next generation systems development projects from feasibility through regulatory clearance/approval.
o Formulate reagents and conduct experiments.
o Complete projects within timeline and budget.
o Develop methods or designs to meet product specifications and cost targets.
o Create validation protocols, including reports and technical briefs.
o Generate and collect data for 510(k) submissions.
o Coordinate and/or interact with appropriate departments during all phases of the project.
o Submit and/or report appropriate information or documents to management, peers, departments and regulatory agencies.
o Manage laboratory instrumentation.
o Minimum of a BS degree in chemistry or related field.
o 2-3 years of industrial experience in research and development of immunoassays.
o Experience in project planning and implementation.
o Working knowledge of QSR/ISO product development guidelines.
Skills or Attributes:
o Computational including Microsoft Word, Excel, and Powerpoint.
o Design of experiments/statistical methods.
o Work effectively under pressure for meeting goals and objectives of the company.
o Creative, energetic, results oriented team player.
o Good verbal and written communication skills.
Qualigen, Inc. (www.qualigeninc.com) develops, manufactures and distributes the patented FastPack System which is the first blood testing system custom-designed to perform quantitative immunoassay tests in the physician's office laboratory. The current FastPack System menu includes tests for prostate cancer, male aging disorders, thyroid, pregnancy, and vitamin D. Manufacturing of the FastPack System is done at Qualigen's licensed facility under FDA/ISO/CE guidelines. Come join our team of talented people!
Wed, 10 May 2017 13:49:28 PDT