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:

• Bachelors 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 ones 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