"Alerted.org

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