Sr. Scientist, Assay Development

About the Job

The Senior Scientist, Assay 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, Technology, 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.

The Senior Scientist, Assay Development role is an opportunity for an individual to contribute across functions and have a significant impact on FMI. The position is part of the Assay Development team, a sub-team of Product Development, and Research & Development at Foundation Medicine. This individual will help 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.

They will work closely with our Early Research, Technology, Quality, Regulatory, and Operations teams in development of next generation sequencing (NGS)-based assays and will have the opportunity to mentor junior members of the team. This role requires strong working knowledge of molecular biology and NGS workflows, a collaborative approach to science, and strong communication and writing skills.

• 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.
• Lead the development, 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.
• 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.

• Bachelor’s Degree in Molecular Biology, Biochemistry, or Genetics and 11+ years of experience
• OR
• Master’s Degree and 7+ years of experience.
• OR
• PhD and 5+ years of experience.

• PhD or equivalent in Molecular Biology,…