About the Job

The Scientist II, 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.

Key Responsibilities

• Collaborate with molecular biologists, computational scientists and regulatory scientists to support the feasibility and development of clinical oncology NGS diagnostic assays.
• Utilize strong data analysis interpretation and troubleshooting to identify methods to optimize assay features.
• Design and conduct required feasibility and development and validation work, and help to draft standard operating protocols.
• Conduct investigations and analyses to improve assay capabilities and technical robustness, enhance existing methods and complete troubleshooting to optimize assay performance.
• Establish performance specifications for NGS assays and partner with stakeholders for implementation.
• Author detailed, accurate, and accessible records of experimental data and protocols, plans and reports within the Quality Management System as needed.
• Monitor and evaluate analytical aspects of new and emerging technologies.
• Present scientific and technical data to colleagues in a clear and cohesive manner that adapts to varying levels of knowledge of recipients.
• Contribute to project team deliverables according to project schedules / timelines.
• Other duties as assigned.

Qualifications:

Basic Qualifications:

• Bachelor’s Degree in chemical, physical or biological science or medical technology and 8+ years of industry experience; OR,
• Master’s Degree in chemical, physical or biological science or medical technology and 4+ years of industry experience; OR,
• PhD in in chemical, physical or biological science or medical technology and 2+ years of industry experience

Preferred Qualifications:

• Advanced Degree (Master’s Degree+) in Molecular Biology, Biochemistry or Genetics
• 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
• Experience with Hamilton products, robotic liquid handlers, lab automation and instrumentation
• Strong scientific understanding of molecular biology and genomics
• Competency in complex molecular biology techniques, including NGS workflows
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to FMI Values: passion, patients, innovation and collaboration

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