Molecular Diagnostics Expert
3 days ago
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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