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.

Key Responsibilities

• 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.

Qualifications:

Basic Qualifications:

• 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.

Preferred Qualifications:

• PhD or equivalent in Molecular Biology, Biochemistry, or Genetics
• 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), study 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
• 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: Integrity, Courage, and Passion 

The expected salary range for this position based on the primary location of Boston, MA is $140,000 - $165,000 per year. The salary range is commensurate with FMI’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for FMI benefits.

#LI-Onsite