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About the Job
The Senior Scientist, Assay Development leads the development, optimization, and deployment of projects and initiatives on a cross-functional team that distill the latest advances in genomic science, technology and clinical data into innovative, best-in-class clinical diagnostic tools. A particular focus of this position is guiding feasibility and development work on NGS-based clinical products towards monitoring and distributed application. The position collaborates with internal teams as well as outside partners for assay design, performance evaluation, study design at various product development stages, and contributes to laboratory documentation activities under 21 CFR part 820 QSR Design Control.
The position requires a strong working understanding of molecular biology and next generation sequencing including data interpretation, and assay development and regulatory experience in a dynamic multidisciplinary environment. Senior Scientist, Assay Development works in an environment where chemicals and reagents are present.
• Lead the feasibility and development stages of clinical NGS product development aimed at monitoring and distributed application.
• Lead training and performance qualification testing during tech transfer between the development and operations teams.
• Lead product documentation in fulfillment of Quality System Requirements design control, including CDx assay requirements, functional specifications, performance and study results, and data management.
• Partner collaboratively with the Quality Assurance and Regulatory Teams to ensure that all 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 results at group meetings, to external collaborators.
• Contribute scientific understanding to identify assay parameters and deliver this information throughout projects and initiatives described above.
• Other duties as assigned.
• Bachelor’s Degree
• 8 years of experience in the scientific industry
• Advanced Degree in Molecular Biology, Biochemistry, Genetics or Cancer Genetics
• 6 years of commercial science experience in Molecular Biology or Biochemistry
• Experience with the practices and principals of Next Generation Sequencing (NGS)
• Extensive Experience in standard molecular biology techniques and an understanding of the practices and principals of clinical specimen extractions (including FFPE, blood and tissue)
• Strong experience in the development and/or implementation of high complexity clinical genomic assays within a regulated environment
• Experience writing standard operating procedures (SOPs), validation protocols, and reports that fit within requirements of Food and Drug Administration – Quality System Requirements, Clinical Laboratory Improvement Amendments, College of American Pathologists, and International Organization for Standardization
• Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-sequencing and target-enrichment
• Experience with robotic liquid handlers, lab automation and instrumentation
• Ability to understand and analyze data generated on NGS platforms
• Excellent verbal and written communication skills including the ability to interpret and communicate complex scientific results to diverse and multi-disciplinary teams
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
• Demonstrated results orientation through successfully making traction on projects both working independently and collaboratively in a dynamic, fast paced team environment
• Strong interpersonal skills that include excellent skill in collaboration and creative problem solving with other departments and colleagues
• Understanding of HIPAA and importance of privacy of patient data
• Ability to work well under pressure while maintaining a professional demeanor
• Excellent organization and attention to detail
Internal applicants, please use your FMI email address.
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