Nanobiosym
  • 13-Apr-2017 to 12-Jun-2017 (EST)
  • MA, USA
  • Full Time

Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing point-of-care diagnostics 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
  • 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
Nanobiosym
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