Associate Director, Operations Sustaining

Personalis, Inc•Fremont, CA

4h•$180,000 - $215,000•Onsite

About The Position

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. Summary: The Associate Director of Operations Sustaining Support within the Technical Operations group will provide operational and technical support for clinical lab products with focus on NeXT Personal Dx, Personalis’ ultrasensitive molecular residual disease assay. The role involves partnering with a cross-functional team to identify and troubleshoot production related issues and prioritize and drive process improvement opportunities.

Requirements

A BS or MS degree in a molecular biology or related field with a minimum of 10 years of relevant experience.
A minimum of 5 years management experience is required with demonstrated ability to set clear expectations and motivate the team to achieve corporate and team goals.
Hands-on knowledge in Next Generation Sequencing technology, reagent manufacturing, lab automation, LIMS, and bioinformatics pipeline.
Familiarity with operations of high throughput clinical laboratory including order intake, sample accessioning, sample processing, pipeline analysis, and report release.
Ability to distill complex data to actionable corrective actions and process improvement initiatives.
Skilled in analytical thinking, demonstrated quick learner and utilizes data to drive decisions.
Excellent communication skills, good presentation and influencing skills.
Attention to detail and ability to work in a fast paced and regulated environment.
Flexibility and self-initiative to support several simultaneous projects.
Strong executive function skills, particularly in problem solving, working memory, organization, and cognitive flexibility.

Nice To Haves

Experience with liquid biopsy, ctDNA, or molecular residual disease (MRD) assays is highly desirable.

Responsibilities

Direct clinical laboratory sustaining support activities, including but not limited to tracking clinical sample and pipeline issues, troubleshooting, and documenting root cause and resolution.
Serve as the technical liaison between lab operations, client experience, clinical software, data management, pipeline, and quality teams to address sample processing or pipeline failure, process control failure, and customer requests.
Compile and monitor clinical lab product performance metrics (KPIs) and use analytical tools to identify process improvement opportunities to enhance clinical assay turn around time, efficiency, and scalability.
Support QA in non-conformance investigations, corrective and preventive actions (CAPAs), and quality control measures for Personalis clinical products adhering to industry regulations and quality system standards (e.g., CLIA, CAP, NYSDOH, ISO13485, FDA)
Lead, mentor, and grow a team of scientists and data engineers for operation sustaining support, fostering a culture of continuous improvement and technical excellence.
Promote cross-functional collaboration and Personalis’
Additional responsibilities may include remote weekend lab sustaining support.