Molecular Technologist I/II: Diagnostics
NAVERIS is seeking a talented, highly motivated and results-oriented Assay Scientist to join the Diagnostics Development group to support the development and optimization of NavDX assays in our clinical labs. The ideal candidate has product development and clinical lab experience in a dynamic, multidisciplinary environment and a strong working knowledge of molecular biology, high throughput automation and ddPCR.
- Optimize and implement assay features including establishing performance specifications, designing and conducting required development and validation work, and producing final reports and SOPs.
- Conduct investigations and analyses to troubleshoot and enhance existing methods, improving assay capabilities and technical robustness.
- Author detailed, accurate, and accessible records of experimental data and high quality protocols, plans and reports.
- Work with regulatory team members to provide regulatory compliance support including assistance with developing SOP, regulatory submission and approval tracking activities, completing regulatory checklists, assisting with Regulatory inspections for CLIA, CAP and state certification applications
- Experience developing, implementing and supporting high complexity clinical assays in a regulated environment (CLIA, CAP, ISO) including writing standard operating procedures, validation protocols and data reports.
- Extensive experience with molecular biology techniques and an understanding of the practices and principals of ddPCR, and NGS, including DNA-seq and target-enrichment.
- Experience with robotic liquid handlers, lab automation and instrumentation.
- Results oriented with daily focus on working to achieve individual, project and group goals.
- Scientific thought process and understanding of assay parameters illustrating creative approaches to problem solving to inform assay troubleshooting and optimization.
- Strong verbal and written communication skills.
- Collaborative, team-player who enjoys working with diverse groups to accomplish great things.
Education or Experience:
- BSc, MSc, PhD, or equivalent, in Molecular Biology, Biochemistry, Genetics is preferred.
- Minimum 3-5 years working in a regulated laboratory environment (CLIA/CAP).
- Knowledge of laboratory safety protocols.
- Experience with ensuring and maintaining integrity and quality of the lab (including sample processing, equipment, SOPs and quality assurance).
- Experience with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers ,ddPCR etc.)
- Demonstrated ability to work independently and collaboratively in a dynamic, fast paced team environment.