Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. Nanobiosym was awarded the 2013 X-PRIZE- the first X-PRIZE ever awarded for healthcare.
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
PhD 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 qPCR, 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