Scientist I, DD&V

About The Job

The Scientist I, Diagnostic Development & Validation role supports the full product development lifecycle, from concept through commercial launch, of new Next Generation Sequencing (NGS)-based assays under 21 CFR part 820 Quality System Regulations (QSR) Design Control. The position contributes to laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance. The position also performs validation test planning as well as hands-on execution in the laboratory.

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

• Prepare and handle biological specimens including blood, plasma, formalin-fixed paraffin-embedded samples, and extracted nucleic acids.
• Execute development, verification, and validation studies for novel diagnostic NGS assays.
• Process and manage samples using automated workflows and Laboratory Information Management System (LIMS).
• Lead training and performance qualification testing during technology transfer between the product development and laboratory operations teams.
• Author Performance Qualification (PQ) and Process Performance Qualification (PPQ) study protocols.
• Author detailed, accurate, and accessible records of experimental data, present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies (FDA).
• Analyze and compile data for preparation of study reports and generate study reports.
• Prepare and organize study reagents.
• Prepare and document design control documentation, CDx assay requirements, functional specifications, performance and study results, and other data in a QSR-compliant manner.
• Partner collaboratively with the Quality Assurance and Regulatory teams to ensure that all procedural and submission documentation meets audit and accreditation standards.
• Establish and validate performance parameters, quality control, and stability specifications for critical reagents.
• Support the timely processing and reporting of oncology samples to internal and external collaborators.
• Conduct investigations and analyses to troubleshoot and improving assay capabilities, enhance technical robustness and existing methods.
• Other duties as assigned.
  
  

Qualifications

Basic Qualifications:

• Bachelor’s Degree in a life science
• 2 years of directly related industry experience
  
  

Preferred Qualifications

• Ability to work in a laboratory environment where chemicals and regents are present
• PhD in Molecular Biology, Biochemistry, Genetics or Cancer Genetics
• Current California Clinical Laboratory Science or Clinical Molecular Biology license
• Experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment
• Experience in the development and/or implementation of genomic assays in a regulated environment including writing standard operating procedures, validation protocols and reports
• Experience with robotic liquid handlers, lab automation and instrumentation (especially Hamilton)
• Experience developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with Food and Drug Administration-QSR, Clinical Laboratory Improvement Amendments, College of American Pathologists, and International Organization for Standardization regulations)
• Experience writing standard operating procedures (SOPs) validation protocols and data reports
• Track record of successfully managing multiple concurrent initiatives and maintaining one’s own workflow with timely completion ahead of deadlines
• Demonstrated ability to work in a dynamic, fast paced team environment
• Strong cross-functional collaboration and problem solving skills
• Understanding of HIPAA and the importance of privacy of patient data
• Ability to work well under pressure while maintaining a professional demeanor
• Excellent organizational skills and attention to detail
  
  

The expected salary range for this position based on the primary location of Boston, MA is $95,000 - $115,000 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.