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Nanobiosym, Inc. Senior Scientist: IVD Assay Developer in Cambridge, Massachusetts

23-Jan-2024 to 15-Apr-2024 (EST) | 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

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