Scientist II, Diagnostic Development & Validation

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 process and understanding of assay parameters illustrating creative approaches to problem solving to inform assay troubleshooting and optimization
• Strong interpersonal skills that include excellent skills 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