The Position:

Location: This is an onsite position based in our South San Francisco location.

We are looking for a highly motivated individual to join the Veracyte R&D Team as a Principal Scientist for IVD product development. This exciting and challenging role is responsible for leading the development and validation of genomics-based molecular diagnostic assays under design control in the field of oncology. This position requires planning and managing technical studies aimed at establishing and validating genomics assay workflows, test kit components and controls, and performance of IVD assays, along with overseeing technical team members. To be a successful candidate, you will 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.

Responsibilities:

• Oversee development and validation of genomics-based molecular IVD assays using the design control process - inclusive of design, feasibility, optimization, guard-banding, verification, validation and design transfer.
• Mentoring (design, monitor, complete, troubleshoot) of laboratory project tasks performed by product development personnel.
• Lead product development efforts within a multi-disciplinary team that includes project management, clinical, bioinformatics, regulatory, quality and marketing groups.
• Participate in managing the Design History File for new products.
• May participate in other aspects of IVD development and testing to ensure that IVD products conform to product specifications.
• May participate in company audits as it relates to development and validation of IVD assays.

Who You Are:

PhD in chemistry, biochemistry or molecular biology (or related studies) plus extensive relevant industry experience (10+ years, including 7 + years industry), or an B.S./M.S. in chemistry, biochemistry or molecular biology (or related studies) with additional relevant experience (15 + years, including 10+ years industry).

• Prior experience in developing genomics-based IVD assays or laboratory developed tests is required.
• Experience with various molecular platforms (e.g. next-generation sequencing, microarrays and/or qPCR), in the context of assay development and testing of clinical specimens, is required.
• Keen insight into experimental design, aimed at elucidating the biological factors that influence genomic results.
• Hands-on knowledge of the biochemistry underlying multi-component molecular biology methods at the sample preparation, assay and detection level.
• Familiarity with IVD regulations (FDA 21 CFR Parts 820 and ISO 13485:2016) or CLIA regulations.
• Demonstrated effective mentoring (design, monitor, complete, troubleshoot) of laboratory project tasks performed in the hands of others.
• Experience with gene expression is preferred but not required.
• Goal-oriented and timeline-driven to support company objectives. Demonstrated an ability to thrive in a fast-moving environment and acknowledge that product timeliness is essential to commercial success.
• Must be highly motivated team player and work well with others.
• Strong organizational, communication, and interpersonal skills.
• Excellent documentation skills including writing of technical documents.

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