Senior Scientist / Principal Scientist, Product Development - Military veterans preferred

The Position:

We are looking for a Senior Scientist or a Principal Scientist to join the Product Development team. The position is a laboratory-based, individual contributor, position focused on assay development for high-throughput operation, contributing to Veracyte’s novel diagnostic products. This position will significantly contribute to study design, analysis and documentation, execute bench studies while working to strict design control requirements.

Responsibilities:

• Fluent at conception of novel ideas, developing fully interpretable and actionable experimental designs suitable for high-throughput laboratory.
• Have basic bioinformatics knowledge on molecular data to enable data interpretation and appropriate study design.
• Excellent data interpretation skills.
• Independently design workflow appropriate for the implementation in clinical operations, writing SOPs and experimental protocols, and prepare reports that become part of the Design History File and meet FDA-level requirements.
• Develop assays by taking operational implementation into consideration, including automation, QC and LIMS.
• Transfer developed assays from R&D into production, including training and teaching of CLIA laboratory operators.
• Proven success leading projects collaboratively as both intellectually and as a direct contributor at the lab bench, with delivery of results in a timely fashion and partnering with colleagues and across company disciplines.
• Demonstrate effective mentoring of laboratory tasks performed in the hands of others. Contribute collaboratively on the laboratory troubleshooting needs within and outside of R&D.
• Theoretical and hands-on knowledge of the basic biological principles governing molecular biology, genetics, and biochemistry underlying laboratory assays and clinically relevant information.
• Fluency with clinical sample preparation, assay and quality control under high-throughput production conditions at the highest standards of traceability and referential integrity.
• Goal-oriented and timeline-driven in support of company objectives in serving patients. Demonstrated ability to thrive in a fast-moving environment and acknowledge that product timeliness is essential to commercial success.
• Interact seamlessly with multi-disciplinary teams such as automation, laboratory infrastructure (e.g. LIMS), clinical, bioinformatics / data analysis, regulatory and marketing groups.

Who You Are:

• Familiarity with design controls and phase-gate processes in product development, translating that into the insight for experimental design through prioritizing must have over nice to have.
• Extensive bench experience (>8 years) is essential. Must have a willingness to participate directly in routine laboratory activities independently and in cooperation/coordination with others. Must be able to lead others and effectively manage (design, monitor, complete, troubleshoot) laboratory project tasks performed in the hands of others.
• Molecular assay expert. Deep theoretical and hands-on knowledge of the 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/assays in a developed workflow.
• A strong sense of urgency, independent, goal-oriented and timeline-driven.
• Exceptional written and oral communication skills. Able to explain difficult concepts and influence others.
• Proven ability to keep abreast of technological platform advancements and assess their value to the product success and company’s endeavors.
• 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: D. in biology, molecular biology, genetics or a related field. Domain expertise in cancer is desirable.
• Minimum 8 years of postgraduate laboratory bench experience, with >5 years of industry experience in product development. 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 assay development using molecular genomic technologies (both RNA and DNA), including experience in next-generation sequencing, qPCR, microarray or other high-throughput platforms.
• Genomic data analysis and interpretation/visualization skills.

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