Personalis is a rapidly growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. Our ImmunoID NeXT Platform® is enabling the development of next generation immuno-oncology therapeutics and diagnostics.
The Senior Scientist within the Process/Product Development group will support the development, optimization, validation and documentation of new or existing NGS-based IVD products in a regulated environment (FDA-QSR, CLIA, CAP, ISO regulations). The ideal candidate should be an enthusiastic, flexible team player with IVD product development experience.
- Lead execution of development, verification, and validation studies for NGS-based IVD product.
- Lead documentation effort to support QSR design control, functional specifications, performance and study results, and data management.
- Author SOPs, work instructions, study protocols and write technical reports to support FDA submissions.
- Manage and conduct performance qualification testing to support IVD product development and FDA submission.
- Supervise one or two Junior/Senior Research Associates.
- Work with the Regulatory and Quality Assurance teams to ensure that documentation meets QSR standards.
- Establish and validate performance parameters, quality control, and stability specifications for critical reagents.
- Support the external and internal collaboration to process samples during development and validation studies.
- Design experiments for process characterization, performance qualification of equipment, and development activities to support FDA submission.
- Troubleshoot and enhance existing methods, improving assay capabilities and technical robustness.
- Maintain detailed, accurate, and accessible records of experimental data and present the results at internal meetings.
- Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics with 3 years of experience or M.S. with 5 years of experience in the life sciences industry.
- Experience with assay development and validation for IVD products.
- Demonstrated ability to organize, document, and communicate effectively.
- Demonstrated ability to work in a dynamic fast paced team environment.
- Substantial experience in optimizing laboratory methods and workflows and scaling up molecular biology assays to enable high-throughput laboratory operations.
- Proven success in managing collaborative and individual projects.
- Skilled at writing clear SOPs and validation reports, and experience with quality management, including design control, risk analysis, and mitigation strategies.
- Deep understanding of essential molecular biology methods such as PCR, nucleic acids extraction and purification, quantitation, and quality control is required. Next generation sequencing experience is preferred.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.