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)