Molecular Diagnostics Expert

3 days ago


Cambridge, Massachusetts, United States Nanobiosym Full time
Job Title: Molecular Diagnostics Expert

Nanobiosym is a leading nanotechnology company based in Cambridge, MA, pioneering novel technologies to address complex diseases. Our team of experts works at the interface of physics, nanotechnology, and biomedicine. As a pioneer in our field, we were awarded the 2013 X-PRIZE for healthcare innovation.

We are seeking an experienced Molecular Diagnostics Expert to lead our molecular diagnostic assay development efforts. The ideal candidate will have a strong background in nucleic acid biochemistry, molecular biology, or a related field. A minimum of 7 years of relevant industry experience and IVD assay development expertise is required.

The selected candidate will be responsible for:
  • Developing and implementing molecular diagnostic assays through successful FDA submission
  • Managing and contributing to regulatory documents
  • Project management and personnel management skills
  • Designing assay performance specifications
  • Ensuring the assay development process meets milestones and timelines
  • Troubleshooting and solving technical issues
  • Maintaining compliant laboratory documents and procedures

Required Qualifications:
  • PhD in Nucleic Acids Biochemistry, Molecular Biology, or a related field
  • Minimum 7 years of relevant industry experience and IVD assay development expertise
  • 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)
  • 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

Estimated Salary: $120,000 - $150,000 per year, depending on experience.

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