Full Time | Cambridge | Massachusetts | United States
About the Job
The Senior Scientist, Development Operations sits on the Companion Diagnostics (CDx) Development Operations Team and is responsible for developing companion diagnostics and for contributing to the regulatory strategy of new NGS-based assays under 21 CFR part 820 QSR Design Control. The position advances the full development lifecycle from concept through to commercial launch. Additionally, this position contributes to laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance.
The Senior Scientist of CDx Development, in the Development Operations team (Product Development), reporting to Principal Scientist works on the development of Companion Diagnostics (CDx) through the full development lifecycle and regulatory strategy, from concept through commercial launch, of new NGS-based assays under 21 CFR part 820 QSR Design Control. This position contributes to laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance. The ideal candidate will have a strong working understanding of molecular biology and next generation sequencing including data interpretation, assay development, and regulatory experience. This role will have a unique opportunity to contribute to the development of new CDx assay platforms in the rapidly growing field of diagnostic next generation sequencing. This position requires working in an environment with chemicals and regents present.
• 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.
· developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations).
· writing regulation-adherent validation protocols, data reports and Standard Operating Procedures.
· with the practices and principals of next generation sequencing, including DNA-seq and target-enrichment.
· 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.
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