Scientist I, Assay Development

Foundation Medicine

23h • Onsite

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• Advanced Degree (Master’s Degree+) in Molecular Biology or a related life science field

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.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for Foundation Medicine's benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level