02-Oct-2024 to 30-Dec-2024 (EST) | Cambridge, MA, USA | Full Time 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