Location: Cambridge, MA
Company: Nanobiosym
DUTIES Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission Manage and contribute to regulatory documents Project management; personnel management skills preferred Design assay performance specifications Ensure assay development process meets milestones and timelines Troubleshoot and solve technical issues Maintain compliant laboratory documents and procedures Pro-actively improve efficiency, quality and effectiveness of R & D efforts QUALIFICATIONS Ph D in Nucleic Acids Biochemistry, Molecular Biology, or related field Minimum of 7 years of relevant industry experience and IVD assay development In depth knowledge and hands on experience with q PCR,
sequencing and standard molecular biology techniques Demonstrated technical, managerial and leadership expertise in assay development Strong understanding of FDA and global regulatory requirements Demonstrated experience and understanding of quality systems (e.
g. GLP, ISO, etc. ) Prefer experience working in BSL-2 laboratory facilities Strong work ethic and ability to generate high quality work under tight deadlines Flexibility in work schedule Self-motivated, independent and a driving force of efficient execution Strong organizational and project management skills Excellent oral and written communication skills Job Posted by Applicant Pro
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