Assay Development Scientist
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Accentuate Staffing is seeking an Assay Development Scientist to work for an innovative medical technology company in the RTP. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate will have the proven ability and knowledge to develop reagents, controls and assays from concept through design transfer for in-vitro medical diagnostic devices.
Responsibilities:
- Developing in-vitro diagnostic assays, controls and reagents from concept to design transfer.
- Develop and maintain associated development documentation such as, requirements, design descriptions, test plans test protocols and test summary reports.
- Collaborate with Operations to continuously formulate, develop and optimize the manufacturing and quality control processes for reagents and controls.
- Prepare quantitative analysis, summary and protocol reports, presenting technical findings in meetings.
- Transferring reagent and control designs to manufacturing.
Requirements:
- Degree in Engineering, Life Sciences or a related scientific discipline.
- Experience needed is dependent upon level of education; 5 years of experience minimum with a BS, 3 years of experience minimum with an MS degree and 1 year of experience minimum with a PhD.
- Must have 1 year of experience or more with the development and design control of in-vitro diagnostics.
- Strong knowledge of in vitro diagnostics, clinical applications and coagulation biochemistry highly preferred.
- Ability to use statistical analysis and/or DOE software.
