Candidates cannot begin an assignment without successful drug & background clearances.
*6 month contract assignment in Durham, NC
The Product Development Scientist will actively participate in the design, optimization, verification and validation of molecular diagnostic products. This will require both independent and directed laboratory work to design, collect, analyze and interpret data acquired from PCR based molecular assay platforms.
This associate will provide strong technical and laboratory input in the field of infectious disease.
-Apply knowledge of molecular biology to develop amplification based molecular diagnostic assays for infectious diseases.
-Analyze complex data using statistical analysis tools and present findings to the R&D team.
-Participate with cross-functional teams to develop and execute verification and validation protocols.
-Operate, maintain, and troubleshoot assay automation equipment
-Possess computer skills necessary to utilize commercial software packages such as; data analysis, spreadsheets, word processing, and molecular biology specific programs.
-Maintain organized and accurate laboratory notebooks according to the guidelines of the quality system and GLP.
*Position requires working with infectious biological materials including human stool.
- A minimum of 2 years product development experience in a regulated environment is mandatory. Prior verification and validation experience strongly preferred.
- A strong background in molecular biology with working knowledge of cloning, qPCR, RT-PCR, assay optimization, and nucleic acid isolation is mandatory. Experience developing multiplexed molecular diagnostic assays is desirable.
- Ability to design, execute, and analyze experiments under general supervision.
- Knowledge of statistical analysis as it applies to assay development is required.
- Working knowledge of software typically used for molecular biology, bioinformatics, data analysis, and reports.
- Experience working with infectious biological specimens is required.
- Experience with operating and troubleshooting laboratory automation equipment is desirable.
- Excellent communication skills (written and oral) and the ability to work in a team environment are critical