Senior Scientist

Profile

\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\u003eQualifications\u003c/strong\u003e\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 : http://www.foundationmedicine.com