R&D SCIENTIST

Department: Research Development

The R&D Scientist is expected to independently design, execute and analyze studies with guidance and prioritization given from the Director of R&D.  The R&D Scientist prepares research protocols, summaries, reports in accordance with Design Controls per FDA, ISO and IVD Directive standards while supporting the Quantimetrix quality policy.

RESPONSIBILITIES:

  • Performs discovery, research, development, product transfer, activities for new products and product improvement projects
  • Projects may include new or improved quality controls, calibrators, proficiency materials, reagent, and assay systems for the clinical diagnostic/medical device industry
  • Works with closely with partner companies when developing OEM products
  • Assists with product transfer and validation activities while supporting manufacturing, QC and RA/QA groups
  • Provides documentation, data analysis, summaries, reports in accordance with the Design Control procedure per FDA< ISO and IVD Directive standards
  • Maintains laboratory notebooks and prepares Design History Files for each project
  • Presents research work within and outside the R&D group
  • Drafts manufacturing batch records and related SOPs and Work Instructions
  • May be expected to travel and attend conferences and trade show

REQUIREMENT FOR THE POSITION:

  • Minimum M.S. in biochemistry, chemistry clinical chemistry or similar with 5 years of relevant experience or B.S. with 10 years of relevant experience.
  • Ability to design and conduct experiments without direct supervision
  • Ability to analyze and present data in a coherent and scientifically valid manner
  • Knowledge of assay troubleshooting and development
  • Basic use of Excel spreadsheet and statistics
  • Experience working under CGMPFDA/ISO regulations
  • Excellent communication skills (both verbal and written)

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