Senior Scientist: IVD Assay DeveloperNanobiosym 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.DutiesLead molecular diagnostic assay development in a hands-on manner through successful FDA submissionManage and contribute to regulatory documentsProject management; personnel management skills preferredDesign assay performance specificationsEnsure assay development process meets milestones and timelinesTroubleshoot and solve technical issuesMaintain compliant laboratory documents and proceduresPro-actively improve efficiency, quality and effectiveness of R & D effortsQualificationsPhD in Nucleic Acids Biochemistry, Molecular Biology, or related fieldMinimum of 7 years of relevant industry experience and IVD assay developmentIn depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniquesDemonstrated technical, managerial and leadership expertise in assay developmentStrong understanding of FDA and global regulatory requirementsPrefer commercial assay experienceDemonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)Prefer experience working in BSL-2 laboratory facilitiesStrong work ethic and ability to generate high quality work under tight deadlinesFlexibility in work scheduleSelf-motivated, independent and a driving force of efficient executionStrong organizational and project management skillsExcellent oral and written communication skills