Senior Scientist: IVD Assay Developer

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