What are the responsibilities and job description for the Senior Scientist: IVD Assay Developer position at CHEManager International?
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
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
- 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