Scientist Iii

We are looking for a highly motivated individual to join the Product Development group for the position of Scientist III. This is an on-site, laboratory-focused, individual contributor role focused on assay development for high-throughput operation, contributing to Veracyte's novel diagnostic product pipeline. This position will significantly contribute to study design and documentation, execute bench studies while working to strict design control requirements. This position will be onsite in our San Diego office.

Responsibilities:

• Fluent at developing fully interpretable and actionable experimental designs. Excellent data interpretation skills.
• Independently develop SOPs, 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.
• Transfer developed assays from R&D into production, including training and teaching CLIA operators.
• Proven success executing projects collaboratively as both an intellectual level and as a direct contributor at the lab bench, with delivery of results in a timely fashion.
• 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.
• Application of basic biological principles (molecular biology, genetics, and/or biochemistry) to new product design and optimization.
• Fluency in sample preparation for different clinical sample types, such as blood, FFPE, and nasal swabs.
• Proficiency in assay and quality control under high-throughput production conditions at the highest standards of traceability.
• 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.
• 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:

• Keen insight into experimental design through prioritizing must-have over nice-to-have for operational implementation.
• Expertise in executing projects from development to transfer to clinical operations, and delivery of results in a timely fashion, by overseeing assigned staff and interacting across company disciplines.
• Extensive 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 effectively manage (design, monitor, complete, troubleshoot) laboratory project tasks performed in the hands of others.
• Hands-on knowledge of the biochemistry underlying high complexity molecular methods at the sample preparation and assay level. A track record of successfully troubleshooting and optimizing molecular biology techniques/assays in a commercial context.
• Goal-oriented and timeline-driven with a strong sense of urgency.
• Exceptional written and oral communication skills.
• Ability to work independently, exercise good judgment.
• Excellent teamwork, collaboration and interpersonal skills
• 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 and tact when working with external and internal collaborators.
• Flexibility and open-mindedness in the face of shifting resources & priorities.
• Familiarity with design controls and a phased-gate approach to product development (nice-to-have).
• 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:
  • Ph.D. in biology, molecular biology, genetics or a related field. Minimum of 5 years industry experience and at least 5 years laboratory bench experience required.
  • Or MS/BS in biology, molecular biology, genetics or a related field. Minimum of 8-10 years industry experience required.
• Domain expertise in cancer is desirable.
• 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, microarray, or other high-throughput platforms.
• Genomic data analysis and interpretation/visualization skills.