Senior Process Development Scientist

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 Process Development Scientist 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:

• Lead the development, improvement and scale up of new and existing methods and transfer of tests to production.
• Lead automated method development including the automation of manual processes using high throughput robotic liquid handlers.
• Design experiments for process characterization, performance qualification of equipment, and development activities.
• Prepare the documentation for process validations and operating procedures and reports and ensure the successful implementation in the labs.
• Building rapport with end-users, lab supervisors and process owners, coordinate with cross functional projects teams, and lead the Operation Qualification and Validation studies for process optimization and technology transfer efforts.
• Additional responsibilities include mentoring junior staff, user training, troubleshooting, optimizing the workflows, and on-going support for the end-users.

Requirements:

• Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics with at least 3 years of experience or M.S. with 6 years of experience in molecular biology research and development, human genomic sequencing, and related fields, with emphasis on Process development and optimization of diagnostic assays in a CLIA regulated laboratory 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, and risk analysis and mitigation strategies.
• Hands-on scientist, experienced with adapting and validating assays for automated processes and continuous workflows.
• Deep understanding of essential molecular biology and methods such as PCR, nucleic acids extraction and purification, gel electrophoresis, analysis tools and instrumentation, DNA quantitation, and quality control is required. Next generation sequencing experience is a plus.

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

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