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