Senior IVD Assay Scientist - FDA Submissions & Leadership

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

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.