We are looking for a highly motivated individual to join the Product Development team for the position of Senior Scientist. The position is an individual contributor position within the Product Development team focused on assay development for high-throughput operation, contributing to Veracytes novel diagnostic products. This position will significantly contribute to study design 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.
• Bioinformatics knowledge on molecular data to enable data interpretation and appropriate study design.
• 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 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.
• Mentor laboratory tasks performed in the hands of others. Contribute collaboratively on the laboratory troubleshooting needs within and outside of R&D.
• Interact seamlessly with multi-disciplinary teams such as automation, laboratory infrastructure (e.g. LIMS), clinical, bioinformatics / data analysis, regulatory and marketing groups.

• 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 (>6 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 mentor others and effectively manage (design, monitor, complete, troubleshoot) laboratory project tasks performed in the hands of others.
• Excellent data interpretation skills.
• 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.
• 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.
• 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.
• 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 companys 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 6 - 7 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) strongly preferred.
• Strong background in assay development using molecular genomic technologies (both RNA and DNA), including experience in next-generation sequencing platforms.
• NGS-based genomic data analysis and interpretation/visualization skills.

#LI-Onsite, #LI-Hybrid, or #LI-Remote