Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing novel technologies 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 • Prefer commercial assay experience • 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