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
