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This will primarily be a hands-on, bench level position with a major focus on developing real-time PCR assays to identify bacterial pathogens in a variety of clinical specimens.
The candidate must have the skills and knowledge associated with successful in vitro diagnostic (IVD) product development.
The candidate will be involved in all aspects of assay development including sample preparation, design of nucleic acid isolation methods from different sample types, design of highly multiplexed, real-time PCR and RT-PCR assays, creating and validating test methods, and systems integration.
The candidate will insure that all design requirements for the assay are met or exceeded and document each step of development according to company protocols.
The successful candidate must be capable of hands-on work at the bench as well as directing others to meet timelines successfully.
The candidate must have documented experience in molecular biology, including PCR and DNA sequence analysis. S/he must have extensive experience in the design and development of highly multiplexed real-time PCR assays, with a proven track record of interfacing between development, production, and quality systems during the development of FDA-approved IVD products. The candidate should have experience in microbiology including sterile technique, microorganism identification, and antimicrobial susceptibility testing. Strong computer skills including proficiency with Microsoft Word and Excel, statistical software, sequence design software, and literature search technology are required. Excellent written and oral communication skills and proven interpersonal and team skills are required. This position requires an individual who can produce clear, understandable documentation. This position requires a self-driven and flexible contributor who can allocate time and resources efficiently, effectively prioritize, and continually seek ways to improve individual and corporate efficiency.
* Minimum of 5 years industry experience
* BS/MS Microbiology, Molecular Biology, or related scientific discipline (MS preferred)
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