- 13-Feb-2017 to 15-Mar-2017 (EST)
- Cambridge, MA, USA
- Full Time
- Are you a hands-on scientist who wants an opportunity to lead molecular assay development from design through successful regulatory (including FDA) submissions?
- Do you get excited at the thought of reporting into the Founder, Chairman and CEO who is a renowned MIT and Harvard trained Physician and Physicist?
- Can you imagine yourself at a Cambridge, MA company that is on the cusp of rewriting the rules of personalized medicine, mobile diagnostics, and healthcare delivery?
We have a fantastic opportunity at Nanobiosym for a Sr. Scientist, IVD Assay Developer who will have the opportunity to do challenging work, and have a critical role on a team that values high performance, high quality and innovation.
A Typical Day:
- Evaluate the scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the assay design
- Manage and contribute to regulatory documents
- Ensure assay development is consistent with FDA and other regulatory guidance
- 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
- Generate high-quality experimental data, including design and analysis
- Contribute to existing technology and product development
- Complete verification and validation of assays on bench and instrument
- Deliver high quality technical reports and scientific presentations
Do You Have:
- PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field
- Minimum of 7 years of relevant industry experience in IVD assay development through to assay launch
- 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 under which products are developed, commercialized and supported
- Demonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)
- Experience working in BSL-2 laboratory facilities is preferred
- Strong work ethic and ability to generate high quality work under tight deadlines
- Self-motivated, independent and a driving force of efficient execution
- Strong organizational and project management skills
- Excellent oral and written communication skills
We are smart, passionate, fearless, focused and steadfast in our mission. If we're going to rewrite the rules, we have to work hard, and that means we typically work more than a 40-hour workweek. We do it because we love what we do, and we're working to deliver world class healthcare to the over 7 billion people living on Earth today. Our hard work doesn't go unnoticed; we were awarded the first ever XPRIZE for healthcare for which we are immensely proud.
If all of this sounds like it was written for you, we'd love to receive your application and resume.
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