Would you like to work for an organization that is like no other! Does the combination of science, healthcare and technology intrigue you? Are you a scientist that can think outside the box? If so, then you may want to read on………..

Our client is a startup organization that is an innovative nanotechnology company in Cambridge, MA, that is developing point-of-care diagnostics to address a broad range of diseases.

POSITION SUMMARY:

This is an exciting opportunity to join a well-funded and exciting company in a fast-paced environment.

The Senior Scientist performs a variety of tasks associated with IVD assay development through each stage of the process through FDA submission.

• 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
• 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