About the Job
The Scientist II, Diagnostic Development & Validation supports the full development lifecycle, from concept through commercial launch, of new NGS-based assays under 21 CFR part 820 QSR Design Control. This 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 requires 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 (blood, plasma, FFPE samples, nucleic acids).
Develop, verify, and validate novel diagnostic NGS assays.
Process samples using automated workflows and LIMS.
Lead training and performance qualification during technology transfers.
Document experimental data and present findings internally and externally.
Analyze data and generate study reports for regulatory submissions (e.g., FDA).
Prepare and organize study reagents.
Maintain QSR-compliant documentation for CDx assay development.
Collaborate with QA and Regulatory teams to meet audit and accreditation standards.
Establish and validate performance parameters and QC for critical reagents.
Support timely processing and reporting of oncology samples.
Troubleshoot and enhance assay capabilities and technical robustness.
Collaborate with cross-functional teams (molecular biology, computational, regulatory).
Interpret data and optimize assay features.
Design and conduct feasibility, development, and validation studies.
Draft and maintain SOPs and documentation within the Quality Management System.
Monitor and evaluate emerging analytical technologies.
Present scientific and technical data clearly to diverse audiences.
Contribute to project deliverables aligned with timelines.
Perform other duties as assigned.
Comply with FMI's attendance policies
Qualifications
Basic Qualifications
Bachelor’s Degree in chemical, physical or biological science, or medical technology and 4+ years of industry experience; OR,
Master’s Degree in chemical, physical or biological science, or medical technology and 2+ years of industry experience
Preferred Qualifications
Advanced Degree (Master’s Degree or PhD) in Molecular Biology, Biochemistry or Genetics
6+ years of commercial science experience in Molecular Biology or Biochemistry
Current California Clinical Laboratory Science or Clinical Molecular Biology license
Strong scientific understanding of molecular biology and genomics
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; experience writing standard operating procedures, validation protocols and data reports within these environments
Experience with Hamilton products, robotic liquid handlers, lab automation and instrumentation
Demonstrated ability to clearly communicate scientific results in internal and external presentations and publications
Demonstrated history of meeting individual and collaborative project deadlines
in development, optimization, validation, and implementation of QSR or CLIA-certified tests including writing SOPs and validation plans/reports
Demonstrated track record of timely completion of projects in an industry setting
Excellent technical writing, presentation, and communication skills
Detail oriented with excellent prioritization and organizational skills
Ability to work in the presence of chemicals and reagents
Competent in complex molecular biology techniques, including NGS workflows
Scientific thought…