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About the Job
The Senior Scientist, Product Development helps lead the development, optimization, and deployment of NGS-based 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 or data products and enable oncologists to determine the best treatment throughout each patient’s journey with cancer. This position works closely with the Early Research, Automation, Quality, Regulatory, and Operations teams in development of next generation sequencing (NGS)-based assays, and has the opportunity to mentor junior members of the team.
This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.
Regular onsite work at a designated FMI location is an essential function of this role.
• Meet regularly with a multidisciplinary team of Scientists, Engineers, Computational Biologists and other stakeholders to develop clinical NGS assays.
• Develop and optimize the NGS platform and execute upon action steps identified in stakeholder meetings.
• Guide, coach, direct, and develop direct reports, if applicable.
• Add creative approaches in assay troubleshooting, optimization and problem solving.
• Support, in collaboration with the Business Development, Clinical and Commercial Teams, the strategic external relationships with technology providers, pharmaceutical companies and academic partners through executing upon identified communication steps and presenting information pertaining to scientific work at FMI.
• Lead the optimization and deployment of genomic methodologies including high throughput automation and NGS-based systems and workflows.
• Lead, author, and execute development studies for novel diagnostic next generation sequencing assays.
• Work collaboratively with the Early Research team to guide technology transfer into development.
• 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.
• Work across teams to assist in the setting up of a new R&D laboratory space.
• Other duties as assigned.
• BSc in Molecular Biology, Biochemistry, or Genetics and 5+ years of post-graduate experience; OR,
• Master’s Degree and 3+ years of post-graduate experience; OR,
• PhD Degree and 1+ year(s) of post-graduate experience
• PhD or equivalent in Molecular Biology, Biochemistry, or Genetics
• Current California Clinical Laboratory Science or Clinical Molecular Biology license
• 8+ years of commercial science experience in Molecular Biology or Biochemistry
• Extensive experience with the practices and principles of Next Generation Sequencing (NGS), including DNA-sequencing and target-enrichment
• 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
• Experience with robotic liquid handlers, lab automation and instrumentation
• 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
• Demonstrated ability to clearly communicate scientific results in internal and external presentations and publications
• Demonstrated ability to work independently and collaboratively in a dynamic, fast-paced team environment
• Ability to understand and analyze data generated on NGS platforms
• Strong interpersonal skills that include excellent collaboration and creative skills
• Excellent verbal and written communication skills including the ability to interpret and communicate complex scientific results to diverse and multi-disciplinary teams
• Strong problem-solving skills with other departments and colleagues
• Excellent organization and attention to detail
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: passion, patients, innovation, and collaboration
Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.
Internal applicants, please use your FMI email address.
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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
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