Scientist I, Assay Development

About The Job
The Scientist I, Assay Development supports the late-stage development and optimization of next generation sequencing (NGS) based assays in our clinical labs. Leveraging strong working knowledge of molecular biology, the incumbent in this position partners closely with other scientists and stakeholders cross functionally on high throughput automation and advancing NGS. The Scientist I prepares and analyzes human specimens, conducts laboratory experiments within guidelines and operates and maintains complex scientific equipment, such as high throughput liquid handlers. Additionally, the Scientist I evaluates and summarizes results, contributes to reports, presents data, and remains up-to-date with current publications relative to methods and techniques within relevant areas of research to leverage and integrate these.

The Scientist I will work within the Assay Development group to help drive updates to Foundation Medicine's comprehensive genomic profiling (CGP) assay. The main responsibilities of the Scientist I will be to contribute to the planning, execution and analysis of the laboratory experiments for the assessment and development of assay improvements. This role will have the unique opportunity to work cross-functionally in a product development environment to advance Foundation Medicine's market-leading CGP tests focused at improving outcomes for cancer patients.

Key Responsibilities

• Independently execute specialized and complex molecular biology techniques, including NGS workflows.
• Collaborate with molecular biologists, computational scientists and regulatory scientists to support the feasibility and development of clinical oncology NGS diagnostic assays.
• Design and conduct required feasibility and development and validation work, and help to draft standard operating protocols.
• Operate complex laboratory equipment such as laboratory automation equipment.
• Utilize data analysis interpretation and troubleshooting to identify methods to optimize assay features.
• Author detailed, accurate, and accessible records of experimental data and protocols, plans and reports within the Quality Management System as needed.
• Prepare reports and presentations to communicate results in group meetings.
• Train and mentor research assistants and/or research associates on optimal processes and standard operating procedures.
• Other duties as assigned.

Qualifications
Basic Qualifications:

• Bachelor's Degree in Molecular Biology or a related life science fields and 6+ years of experience
• OR
• Master's Degree in Molecular Biology or a related life science field and 2+ years of experience
• OR
• PhD and 0 years of experience

Preferred Qualifications

• Advanced Degree (Master's Degree+) in Molecular Biology or a related life science field
• Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq, NGS library preparation and target-enrichment
• Experience developing, implementing and supporting high complexity clinical assays
• Experience within the following regulated environments: Food and Drug Administration – Quality System Regulation, Clinical Laboratory Improvements Amendments, International Organization for Standardization and CAP, and in writing standard operating procedures, validation protocols and data reports within these environments
• A "results-oriented attitude", demonstrated through a history of meeting individual and collaborative project deadlines
• Scientific thought process and understanding of assay parameters illustrating approaches to problem solving to inform assay troubleshooting and or optimization.
• Good interpersonal skills that include excellence in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: Integrity, Courage, Passion