About the Job

The Senior Scientist, Assay Development will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit.

The Senior Scientist, Assay Development contributes to our cutting-edge research initiatives to develop robust cancer detection solutions. The successful candidate will play a key role in advancing our work by optimizing immunoassay 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

• Utilize commercially available immunoassay technologies for protein detection and analysis. 
• Contribute to the setup and maintenance of the protein lab. 
• Design and execute experiments and interpret results to support product development objectives. 
• Independently implement development work according to rough specifications using known methods. 
• Contribute to the development of products, while ensuring compliance with regulated bodies such as the FDA. 
• Collaborate with teams to integrate protein and genomic data. 
• Work cross-functionally to ensure successful technical transfer of methods and workflows to the Operations team. 
• Provide technical expertise and mentorship to junior team members. 
• Present results at group meetings and prepare technical documents under design control. 
• 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. 
• Several years of experience with biochemical and immunological processes. 

Preferred Qualifications:

• Familiarity with FDA regulations and experience working on FDA-regulated products.
• Experience or familiarity with the Roche Cobas high-throughput immunoassay platforms.
• 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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