Scientist I (Contract, 9 months)
About the role
This position is a mainly laboratory-based individual contributor focused on assay development for high-throughput operation, contributing to Veracyte’s novel diagnostic products. This position will significantly contribute to study design, documentation, and executing bench studies while working with the highest rigor and quality standards required for regulated test development.
Responsibilities
- Support analytical validation readiness through planning, laboratory execution, and analysis of characterization studies using in-development automated NGS assay workflows.
- Procure, qualify, and prepare contrived and clinical test samples for pre-AV characterization and validation studies.
- Contribute to fully interpretable and actionable experimental designs in collaboration with senior technical leads.
- Develop SOPs, experimental protocols, and prepare reports that become part of the Design History File under the quality management system.
- Support reagent, equipment, and sample logistical planning for verification and validation study execution in the CLIA lab.
- Support development and transfer of novel automated assays from R&D to production.
- Contribute collaboratively on the laboratory troubleshooting needs within and outside of R&D.
- Use hands-on assay knowledge, advanced molecular biology, genetics, and biochemistry principles, and clinically relevant information to inform study design, data analysis, and development optimization.
- Fluency with clinical sample preparation, assay and quality control under high-throughput production conditions at the highest standards of traceability and referential integrity.
- Interact seamlessly with multi-disciplinary teams such as automation, laboratory infrastructure (e.g. LIMS), clinical, bioinformatics / data analysis, regulatory and marketing groups.
Requirements
- PhD in biology, molecular biology, genetics or a related field. Domain expertise in cancer is desirable.
- A minimum of 3 years of biotech industry experience, and/or postdoctoral experience. Relevant industry experience under Design Control and associated Quality Systems in regulated product development (LDT / diagnostics, PMA or 510(k) device, CE-mark, IVD) strongly preferred.
- Strong background in molecular genomic technologies (both RNA and DNA), including experience in next-generation sequencing, microarray or other high-throughput platforms.
- Genomic data analysis and interpretation/visualization skills.
What We Can Offer You
- Competitive compensation and benefits.
- Committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development.