Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited.

Summary:

The Senior Research Associate within the Process/Product Development group will support the assay development and documentation for new or existing NGS-based IVD products in a regulated environment (FDA-QSR, CLIA, CAP, ISO regulations). This role requires a broad knowledge of molecular biology techniques and IVD product development experience.

Responsibilities:

• Author SOPs, protocols, reports and other documentation to support IVD product development under QSR design control.
• Execution of development, verification, and validation studies for NGS-based IVD products.
• Independently design experiments for process characterization, performance qualification of equipment, and other development activities to support FDA submission.
• Perform standard molecular biology techniques and complex optimization experiments in the areas of Next Generation Sequencing.
• Operate complex laboratory equipment including high throughput robotic liquid handlers.
• Collaborate with other development scientists to conduct guard banding, stability studies, and verification/validation for reagents and assays.

Requirements:

• B.S with 3 - 5 years of work experience in the life science industry.
• M.S with 2 years of work experience in the life science industry.
• Experience with IVD product development and validation under an FDA regulated environment.
• Understanding of essential molecular biology methods such as PCR, library preparation for NGS, nucleic acid extraction, purification and quantification.
• Skilled at writing clear SOPs, work instructions, protocols, validation reports, and experience with Quality System Regulations (QSR) part 820 or CLIA/CAP compliant laboratory.
• Self-driven and able to organize and prioritize a diverse set of responsibilities.

Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.

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