Senior Scientist: IVD Assay Developer

Nanobiosym; Cambridge (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

A leading nanotechnology company in Cambridge, MA, seeks a Lead Molecular Diagnostic Assay Developer to advance diagnostic technologies. This role involves hands-on development, regulatory management, and project oversight to successfully submit assays to the FDA. The ideal candidate will have a PhD, extensive industry experience, and strong leadership skills.

Qualifications

• Minimum of 7 years of relevant industry experience and IVD assay development.
• Demonstrated technical, managerial and leadership expertise in assay development.
• Strong understanding of FDA and global regulatory requirements.

Responsibilities

• Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission.
• Manage and contribute to regulatory documents.
• Ensure assay development process meets milestones and timelines.

Skills

qPCR

Nucleic Acids Biochemistry

Molecular Biology Techniques

Project Management

Leadership

Regulatory Requirements

Quality Systems

Communication

Education

PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field

Job description

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

• 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

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