The Position:

We are looking for a highly motivated individual to join the Veracyte R&D Team as a Scientist II. This individual will play an integral role in developing genomics-based molecular diagnostic assays in the field of oncology. This position requires planning, executing, and managing technical studies aimed at establishing genomics assay workflows, developing test kit reagents and controls, and evaluating the performance of diagnostic tests. To be a successful candidate, we would like you to share our commitment to teamwork and collaboration and be excited by the challenges of applying your scientific expertise to develop genomic tests that improve patient diagnosis and treatment. This is a onsite position based in our South San Francisco laboratory.

Responsibilities:

• Plan and conduct laboratory experiments to develop molecular diagnostic tests based on genomics - inclusive of study design, feasibility testing, optimization, data analysis, and presentation of results.
• Develop SOPs, experimental protocols, and technical reports related to experimental studies testing new or existing diagnostic products that become part of the Design History File and regulatory filings.
• Participate in other key aspects of diagnostic test development, including verification and validation testing, to ensure that IVD products conform to product specifications.
• Collaborate closely with other technical team members, including mentoring and overseeing the work of technical research associates where required.
• Interact seamlessly with multi-disciplinary teams such as the data analysis team, clinical, bioinformatics, and quality to develop new IVD assays.

Who You Are:

• PhD in chemistry, biochemistry or molecular biology (or related studies) plus extensive relevant industry experience (5+ years), or an B.S./M.S. in chemistry, biochemistry or molecular biology (or related studies) with additional relevant experience (8 + years).
• Prior experience in developing molecular IVD assays, genomics assays, or laboratory developed tests is required.
• Experience with various molecular platforms (e.g. next-generation sequencing, microarrays and/or PCR), in the context of assay development and testing clinical specimens. Experience with NGS protocols is strongly preferred.
• Hands-on knowledge of the biochemistry underlying multi-component molecular biology methods at the sample preparation, assay and detection level.
• Keen insight into experimental design, aimed at elucidating the biological factors that influence genomic results.
• Strong organizational, communication, and interpersonal skills; including demonstrated ability to work well with others in team environment.
• Ability to translate experimental results into technical reports and presentations.
• Goal-oriented and timeline-driven to support company objectives.
• Familiarity with IVD regulations (FDA 21 CFR Parts 820 and ISO 13485:2016) or CLIA regulations is desired.

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