Scientist III, Diagnostic Product Development (Contract)
About The Position
We are looking for a highly motivated individual to join the Veracyte R&D Team as a Scientist III. This position requires planning and executing technical studies aimed at evaluating the performance of molecular in vitro diagnostic tests in the field of oncology. 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. Location: This is an onsite position based in our South San Francisco office. Contract length: 12 months
Requirements
- PhD in chemistry, biochemistry, molecular biology, or a related field with 5+ years of relevant industry experience, or a BS/MS in the same fields with 8+ years of experience.
- Prior experience in developing and/or verifying molecular IVD assays, genomics assays, or laboratory developed tests is required.
- Experience with molecular platforms (e.g. next-generation sequencing, microarrays and/or qPCR) in the context of assay development and testing clinical specimens. Experience with NGS protocols is strongly preferred.
- Prior experience with IVD assay Verification and/or Validation study design, planning, lab execution and documentation is strongly preferred.
- Hands-on knowledge of the biochemistry underlying multi-component molecular biology methods at the sample preparation and assay level.
- 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.
- Familiarity with IVD regulations (FDA 21 CFR Parts 820 and ISO 13485:2016) or CLIA regulations is desired.
Responsibilities
- Participate in diagnostic test development, inclusive of development and verification testing, to ensure that IVD products conform to product specifications
- Participate in writing study protocols and technical reports related to development and verification studies testing diagnostic products that become part of the Design History File and regulatory filings.
- Collaborate with technical team members to conduct laboratory experiments and document testing.
- Interact with multi-disciplinary teams such as the data analysis team to coordinate data transfer.
Benefits
- We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions.
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What This Job Offers
Career Level
Mid Level
Education Level
Ph.D. or professional degree
