Product Development Scientist 

Job Title:                                    Product Development Scientist

Experience Required:             See Below

Education Required:                See Below

Number of Openings:              1

Job Start Date:                          ASAP

Reports To:                              Director of Product Development

Duties:

Oversee all phases of product development of in vitro diagnostic medical tests employing lateral flow assay testing.  Develop and oversee execution of all testing protocols, including protocols for technology transfer testing, verification testing, risk testing, validation testing, and project transfer to manufacturing.  Oversee design control process, including identifying user needs, design inputs, verification studies, validation studies, input and output consistency, and assessment of satisfaction of user needs.  Analyze test data, identify root cause, and lead problem resolution process.  Write reports for all product development testing and validation.  Write draft manufacturing procedures for assigned projects.  Oversee product development technicians.  Support/direct manufacturing team during transition from product development to product manufacturing.

 

Required qualifications:

B.S. Biology, Chemistry, Chemical Engineering or similar scientific field.  Two years’ research or development experience with in vitro diagnostics.  Two years’ experience developing or testing lateral flow assays in compliance with FDA/ISO regulations, such as ISO 13485 and FDA Part 820.

 

Prevailing working conditions offered.  Only persons with authorization to work permanently in the U.S. need apply. Contact:  Jen Morio, Manager, 1200 Stewart Place, Springdale, AR 72764.  EOE.