Overview
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.
Responsibilities
* 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
* 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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