Senior Scientist: IVD Assay Developer

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