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Job Details

Senior Scientist

Company name
Foundation Medicine, Inc.

Cambridge, MA, United States

Employment Type

Sciences, Scientist, Biotech, Chemistry

Posted on
Nov 25, 2020

Valid Through
Mar 10, 2021

Apply for this job


\u003cp\u003e\u003cstrong\u003eKey Responsibilities\u003c/strong\u003e\u003c/p\u003e
\u003cp\u003e• Lead, author, and execute development, verification, and validation studies for novel diagnostic next generation sequencing assays.\u003c/p\u003e
\u003cp\u003e• Lead training on new processes as they pertain to applicable cross-functional participants.\u003c/p\u003e
\u003cp\u003e• Manage and conduct performance qualification testing during tech transfer between the development and operations teams.\u003c/p\u003e
\u003cp\u003e• Lead product documentation in fulfillment of QSR design control, including CDx assay requirements, functional specifications, performance and study results, and data management.\u003c/p\u003e
\u003cp\u003e• Partner with the Regulatory and Quality Assurance teams to ensure that procedural and submission documentation meets audit and accreditation standards.\u003c/p\u003e
\u003cp\u003e• Establish and validate performance parameters, quality control, and stability specifications for critical reagents.\u003c/p\u003e
\u003cp\u003e• Support the timely processing and reporting of oncology samples to internal and external collaborators.\u003c/p\u003e
\u003cp\u003e• Conduct investigations and analyses to troubleshoot and enhance existing methods, improving assay capabilities and technical robustness.\u003c/p\u003e
\u003cp\u003e• Author detailed, accurate, and accessible records of experimental data.\u003c/p\u003e
\u003cp\u003e• Present the results of experimental data at internal meetings and with external collaborators.\u003c/p\u003e
\u003cp\u003e• Prepare reports for submission to regulatory agencies ( including the FDA).\u003c/p\u003e
\u003cp\u003e• Other duties as assigned.\u003c/p\u003e
\u003cp\u003e\u003cstrong\u003eBasic Qualifications\u003c/strong\u003e\u003c/p\u003e
\u003cp\u003e• Master’s Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or a related field\u003c/p\u003e
\u003cp\u003e• 6 years working in the life sciences industry and/or academia in a laboratory setting\u003c/p\u003e
\u003cp\u003e\u003cstrong\u003ePreferred Qualifications\u003c/strong\u003e\u003c/p\u003e
\u003cp\u003e• Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field\u003c/p\u003e
\u003cp\u003e• 3 years of working experience in the life sciences industry\u003c/p\u003e
\u003cp\u003e• 3 years of professional experience with molecular biology techniques\u003c/p\u003e
\u003cp\u003e• Experience:\u003c/p\u003e
\u003cp\u003e·   developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations)\u003c/p\u003e
\u003cp\u003e·   writing regulation-adherent validation protocols, data reports and Standard Operating Procedures\u003c/p\u003e
\u003cp\u003e·   with the practices and principals of next generation sequencing, including DNA- seq and target-enrichment\u003c/p\u003e
\u003cp\u003e·   with robotic liquid handlers, lab automation, and instrumentation\u003c/p\u003e
\u003cp\u003e• Excellent organization and attention to detail\u003c/p\u003e
\u003cp\u003e• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow\u003c/p\u003e
\u003cp\u003e• Demonstrated track record of timely work completion ahead of deadlines\u003c/p\u003e
\u003cp\u003e• Strong interpersonal skills in collaboration and problem solving with other departments and colleagues\u003c/p\u003e
\u003cp\u003e• Understanding of HIPAA and the importance of patient data privacy\u003c/p\u003e
\u003cp\u003e• Demonstrated ability to work in a dynamic fast paced team environment and to work well under pressure while maintaining a professional demeanor\u003c/p\u003e
\u003cp\u003e• Ability to work in a laboratory environment in the presence of chemicals and reagents\u003c/p\u003e
\u003cp\u003e• Commitment to reflect FMI’s values: Passion, Patients, Innovation, and Collaboration\u003c/p\u003e

Company info

Foundation Medicine, Inc.
Website :

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