About the Job

The Senior Scientist, Assay Development helps contribute to our cutting-edge research initiatives to develop robust cancer detection solutions. The successful candidate will play a key role in late-stage development, validation of product requirements, and transfer of our NGS assay technologies and workflows. This position works closely with Product Development, Early Research, Technology, Quality, Regulatory, and Operations teams and has the opportunity to mentor junior members of the team.

This is an in-person role based in Boston with potential management opportunities. 

Key Responsibilities

• Meet regularly with multidisciplinary teams of Scientists, Engineers, Computational Biologists, Regulatory, Quality, and Operations to develop, validate, and transfer NGS assays.
• Lead, author, and execute development studies to evaluate and optimize validation sampling strategies.
• Design and execute experiments and interpret results to support product verification objectives.
• Lead validation and transfer of genomic methodologies including high throughput automation and NGS-based systems and workflows. 
• Lead, author and execute FDA facing validation studies in fulfillment of established Quality System Requirements under design control.
• Contribute to the development and validation of products, while ensuring compliance with regulated bodies such as the FDA. 
• Work cross-functionally to lead successful technical transfer of methods and workflows to the Operations team, including training and performance qualification activities.
• Partner collaboratively with the Quality Assurance and Regulatory Teams to ensure that all procedural and submission documentation meets audit and accreditation standards
• Provide technical expertise and mentorship to junior team members. 
• Present results at group meetings and prepare technical documents under design control. 
• Guide, coach, direct, and develop direct reports, if applicable
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree in Molecular Biology, Clinical Lab Science, Biochemistry, Chemistry, Genetics, or related field with 5+ years of experience; OR
• Master’s Degree and 3+ years of post-graduate experience
• Several years of experience with biochemical and immunological processes. 

Preferred Qualifications

• PhD or equivalent in Molecular Biology, Biochemistry, or Genetics
• 8+ years of commercial science experience in Molecular Biology or Biochemistry.
• Familiarity with FDA regulations and experience working on FDA-regulated products
• Strong background in molecular biology, with knowledge of next-generation sequencing platforms or genetics. 
• Track record of successful collaboration with multidisciplinary teams.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills including the ability to interpret and communicate complex scientific results to diverse and multi-disciplinary teams.
• 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.

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