Scientist I, Assay Development

About The Job

The Scientist I, Assay Development, supports reagent implementation activities for new or existing FMI next-generation sequencing (NGS) based assays in our clinical labs. Leveraging a working knowledge of NGS / molecular biology reagents, this position collaborates with internal and external partners on defining technical and quality specifications for critical materials. The Scientist I works independently on drafting documentation in support of implementation of reagents within a Quality Management System. This role interacts with reagent vendors by email and in-person meetings. The role may require execution of NGS workflows / wet lab testing in response to troubleshooting or root-cause investigations. Additionally, the Scientist I evaluates and summarizes results, contributes to reports, presents data, and remains up-to-date with current reagent technologies relative to new methods and techniques within relevant areas of research to leverage and integrate these.

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 implementation of new reagents and materials for use in NGS diagnostic assays.
• Design and conduct required feasibility, development and validation work, as well as, 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 for new materials/product specifications 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
• Knowledgeable with Quality Control workflows, testing and material specifications for critical reagents and materials to be used in diagnostic assays
• Experience authoring documentation under design control within a regulated Quality Management System (e.g., ISO 13485)
• 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 and Passion
  
  

The expected salary range for this position based on the primary location of Boston, MA is $102,000 - $124,000 per year. The salary range is commensurate with Foundation Medicines 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 Foundation Medicine's benefits.