Scientist I (Contract, 9 months)

Veracyte is a global diagnostics company delivering high value insights that empower clinicians and patients to make informed decisions throughout the patient journey. We develop and commercialize advanced diagnostic tests that improve outcomes and reduce unnecessary procedures. Our Product Development team works at the intersection of molecular biology, clinical science, and operational innovation to build the next generation of patient-centric diagnostic solutions.

We are looking for a highly motivated individual to join the Product Development team for the position of Scientist I (contractor). The 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.

• Molecular biology bench experience is required, including hands-on experience with next-generation sequencing (NGS) and related analytical methods for NGS QC (e.g. Tapestation, Fragment analyzer, fluorescence-based quantification, qPCR).
• Must have a willingness to participate directly in routine laboratory activities independently and in cooperation/coordination with others. Must be able to support the design, monitoring, completion, troubleshooting of laboratory project tasks.
• Hands-on knowledge of biochemistry underlying multi-component molecular biology methods at the sample preparation and assay level.
• A track record of successfully troubleshooting and optimizing molecular biology techniques.
• Goal-oriented and timeline-driven in support of company objectives. Demonstrated ability to thrive in a fast-moving environment and acknowledge that product timeliness is essential to commercial success.
• Exceptional written and oral communication skills
• Ability to work independently, exercise good judgment
• Excellent teamwork, collaboration and interpersonal skills
• Excellent problem-solving skills; demonstrated strength intact and diplomacy working with external and internal collaborators
• Flexibility and open-mindedness in the face of shifting resources & priorities
• Willingness to speak up for their interpretations of data or strategy, to ask questions, or to advocate.
• Experience and comfort working effectively within both a direct and dotted-line management structure.

Requirements:

• Education: 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.

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