We are looking for a highly motivated individual to join the Assay Development group for the position of Scientist I. The position is a mainly laboratory-based 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:

• Develop fully interpretable and actionable experimental designs.
• Develop SOPs, experimental protocols, and prepare reports that become part of the Design History File and meet FDA level requirements.
• Transfer developed assay from R&D to production
• Contribute collaboratively on the laboratory troubleshooting needs within and outside of R&D.
• 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.
• 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 essential. 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.
• Experience with various high-throughput molecular biology platforms including next-generation sequencing, microarrays or other hybridization-based detection systems, and qPCR.
• A strong sense of urgency. Be goal-oriented and timeline-driven to support company objectives. Must demonstrate an ability to thrive in a fast-moving environment and acknowledge that product timeliness is essential to commercial success.
• 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.

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