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.
• 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 management.
• 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 collaborators.
• 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 collaborators.
• 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
• 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
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