Senior Scientist, NGS Diagnostics Development & Validation

Foundation Medicine; Boston (MA); On-site; USD 127,000 - 159,000; Full time

Job summary

Foundation Medicine, Inc. is seeking a Scientist II in Boston to support the full development lifecycle of NGS-based diagnostic assays under 21 CFR part 820 QSR Design Control.

The role involves hands-on laboratory work, documentation, and collaboration with cross-functional teams to verify requirements and ensure QA compliance, with a strong focus on assay performance and regulatory-ready data for submissions.

Qualifications

• Bachelor’s degree with 4+ years of industry experience or Master’s with 2+ years of industry experience.
• Advanced degree preferred; 6+ years commercial science experience preferred.
• Licensure in California CLia/CLS is listed among preferred qualifications.

Responsibilities

• Prepare and handle biological specimens (blood, plasma, FFPE samples, nucleic acids).
• Develop, verify, and validate novel diagnostic NGS assays.
• Process samples using automated workflows and LIMS.
• Lead training and performance qualification during technology transfers.
• Document experimental data and present findings internally and externally.
• Analyze data and generate study reports for regulatory submissions (FDA).
• Draft and maintain SOPs and documentation within the Quality Management System.
• Collaborate with QA and Regulatory teams to meet audit and accreditation standards.

Education

Bachelor’s Degree in chemical/physical/biological science or medical technology

Master’s Degree in chemical/physical/biological science or medical technology

Advanced Degree (MS/PhD) in Molecular Biology/Genetics

California Clinical Laboratory Science or Clinical Molecular Biology license

Job description

Foundation Medicine, Inc. is seeking a Scientist II in Boston to support the full development lifecycle of NGS-based diagnostic assays under 21 CFR part 820 QSR Design Control.

The role involves hands-on laboratory work, documentation, and collaboration with cross-functional teams to verify requirements and ensure QA compliance, with a strong focus on assay performance and regulatory-ready data for submissions.