• Lead, author, and execute development, verification, and validation studies for novel
diagnostic next generation sequencing assays.
• Lead training on new processes as they pertain to applicable cross-functional participants.
• Manage and conduct performance qualification testing during tech transfer between the
development and operations teams.
• Lead product documentation in fulfillment of QSR design control, including CDx assay
requirements, functional specifications, performance and study results, and data
• Partner with the Regulatory and Quality Assurance teams to ensure that procedural and
submission documentation meets audit and accreditation standards.
• Establish and validate performance parameters, quality control, and stability specifications
for critical reagents.
• Support the timely processing and reporting of oncology samples to internal and external
• Conduct investigations and analyses to troubleshoot and enhance existing methods,
improving assay capabilities and technical robustness.
• Author detailed, accurate, and accessible records of experimental data.
• Present the results of experimental data at internal meetings and with external
• Prepare reports for submission to regulatory agencies ( including the FDA).
• Other duties as assigned.
• Master’s Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or a related field
• 6+ years working in the life sciences industry and/or academia in a laboratory setting
• Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field
• 3+ years of working experience in the life sciences industry
• 3+ years of professional experience with molecular biology techniques
o developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations)
o writing regulation-adherent validation protocols, data reports and Standard Operating Procedures
o with the practices and principals of next generation sequencing, including DNA-seq and target-enrichment
o with robotic liquid handlers, lab automation, and instrumentation
• Excellent organization and attention to detail
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
• Demonstrated track record of timely work completion ahead of deadlines • Strong interpersonal skills in collaboration and problem solving with other departments and colleagues
• Understanding of HIPAA and the importance of patient data privacy
• Demonstrated ability to work in a dynamic fast paced team environment and to work well under pressure while maintaining a professional demeanor
• Ability to work in a laboratory environment in the presence of chemicals and reagents
• Commitment to reflect FMI’s values: Passion, Patients, Innovation, and Collaboration
Internal applicants, please use your FMI email address.
The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.
Watch the video to see how each member has the chance to make a real impact.