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Research And Development Scientist

3 months ago

Hicksville, United States Acutis Diagnostics Full time

The Research and Development Scientist will perform method development and validations for new assays as well as periodic performance verification of current assay. This individual will assist with the roll out of new methods, QA activities, write SOPs, implement laboratory safety plans, train production staff as it relates to methods they have validated. They will assist with filling out all the paperwork associated with new LDTs submissions to NYS DOH CLEP.


Responsibilities:

  • Research and propose new assays to add to the R&D molecular diagnostics pipeline for eventual use in the clinical laboratory
  • Write comprehensive method validation plans including vendor/stakeholder contact information, criteria for assessment, instrument and equipment allocation, purchasing list, inventory tracking, specimen lists, daily work list, Gantt chart, cost analysis
  • Develop and optimize new and existing molecular assays
  • Perform quantitative and qualitative experiments during method validation in accordance with CLSI, FDA and industry recommendations
  • Perform validation experiments including but not limited to linearity, limit of blank, limit of detection, limit of quantitation, precision, accuracy, interference and stability
  • Develop a comprehensive management scheme that allows for efficient data collection, data reduction, statistical analysis and data visualization in a manner that allows for
  • Maintain analytical instruments and equipment
  • Maintain reagent and consumable inventory
  • Write standard operating procedures and bench excerpts for use in the clinical laboratory
  • Provide hands-on training and competency assessments for staff members at the molecular bench
  • Work with the laboratory directory to create and implement quality control and quality assessment programs for the molecular assays used in the clinical laboratory
  • Troubleshoot issues with existing laboratory assays as they arise


Education Requirements:

  • Bachelor’s Degree in Biology or a related science, required
  • Master’s Degree, preferred

Required Experience

  • 3 years method validation experience in the clinical laboratory or biotechnology industry


Required Skills:

  • Pipetting
  • Laboratory mathematics
  • Serial dilution
  • Meticulous attention to detail
  • Good oral communication
  • Able to read and interpret information
  • Listens and gets clarification
  • Able read information quickly and retain it for use in processing
  • Edits work for spelling
  • Strong technology skills
  • Working knowledge of Microsoft Word, Excel and Outlook
  • Ability to learn
  • Able to work in a team-oriented environment


Physical Requirements:

  • Standing or sitting for an extended period
  • Able to lift 25 lbs.
  • Repetitive wrist motion
  • Audible recognition of alarms