Senior Research Associate, Process Development

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® 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' Clinical Laboratory 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 Development and Automation Engineering group will support the assay development and transfer of new protocols and products into the CLIA production laboratory in a regulated environment (FDA-QSR, CLIA, CAP, ISO regulations). This role requires a broad knowledge of molecular biology and assay development bench techniques, preferably with automation experience.

Responsibilities: 

• Support the development, improvement and scale up of new and existing methods and transfer of tests to production.
• Support automated method development including the automation of manual processes to on high throughput robotic liquid handlers. 
• Perform standard molecular biology techniques and complex optimization experiments in the areas of Next Generation Sequencing.
• Collaborate with other development scientists to conduct guard banding, stability studies, testing and verification for reagents and assays.
• Support the analysis of the experimental data and prepare the documentation including operating procedures and reports, and ensure the successful implementation in the labs. 
• Design experiments for process characterization, performance qualification of equipment, and development activities.

Requirements: 

• B.S with 5 years of work experience in the life science industry.
• M.S with 3 years of work experience in the life science industry.
• 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.
• Proven success working individually and in within a team, detail oriented individual with the proven ability to think logically and innovatively toward problem solving.

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

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