Director, Lab Operations

Personalis, Inc•Fremont, CA

2d•$210,000 - $245,000•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 from biopsy through the life of the patient. 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: We are seeking an accomplished and strategic Director of Laboratory Operations to lead and scale our NeXT Personal laboratory. In this high-visibility role, you will drive operational maturity, ensuring our high-complexity liquid biopsy laboratory functions at the gold-standard. Beyond overseeing daily operations, you will have the autonomy to shape the future of the lab, reporting directly to the VP of Operations with full accountability for departmental AOPs and OKRs. As a Director of Laboratory Operations, you will lead a multidisciplinary team of supervisors and associates to meet increasing demand, directly influencing patient outcomes in oncology. By joining us, you become a catalyst for growth, driving continuous improvement across our RUO, GLP, and CLIA/CAP operations. We are looking for a leader who thrives in a "Team Above Self" environment - someone who will act as a dedicated mentor to develop the next generation of laboratory leaders while ensuring that every sample processed reflects our unwavering commitment to patient care and diagnostic integrity.

Requirements

Education: Bachelor’s Degree in a relevant scientific field (Advanced degree preferred).
Licensure: Current and valid California Clinical Laboratory Scientist (CLS) License preferred. (Generalist or Limited Molecular Biology).
Four (4) to six (6) plus years of experience as California CLS to qualify as Senior Technical Supervisor for the Personalis Molecular Pathology Clinical Laboratory required preferred
Experience: Minimum 10+ years of extensive experience in high-complexity laboratory operations. Must have experience in high volume settings.
Leadership: Minimum 5+ years of management experience with a proven ability to set vision, manage managers, and motivate teams for results.
Technical Proficiency: Deep experience with NGS technologies, root cause analysis, logistics, capacity modeling, and LIMS.

Responsibilities

The Director of Laboratory Operations will be responsible for management and oversight of the RUO, GLP and CLIA/CAP laboratory operation and personnel.
Accountability for overall laboratory operations and clinical test performance in accordance with federal and state regulations
Oversee recruiting, training, and managing testing personnel, ensuring that all employees are adequately qualified and motivated to perform their duties
Oversee validation, assay transfer, and verification of LDTs
Prepare and attend Audits and Inspections(e.g. by pharma clients, CLIA / CAP, NYS, etc.)
Lead a team of CLSs and Technical / General Supervisors
Actively assist and lead, as needed, laboratory related NCs and CAPAs
Attend and actively contribute to the monthly Personalis laboratories Quality Assurance meeting.
Identify and advocate cross functionally for scalable solutions that enhance quality and efficiency
Develop strategic plan and AOP for their department
Champion and lead OKR’s development, execution, and monitoring
Architect capacity models to better understand our labor and equipment requirements
Develop cost models to estimated cost and profit across product lines
Drive an analytical approach to decision making and problem solving
Act as a teacher, mentor, and advocate for personal growth with our young leaders and prepare them for achieving the next levels in their career.
Cultivate both short and long term logistical planning for patient sample processing.
Will own the TAT for the product line and endeavor to continually improve our delivery times
Spearhead a high-performance culture rooted in harmony and a 'team-above-self' mindset. You will champion a solution-focused environment that prioritizes open communication, a sense of belonging, and a commitment to winning as a unified organization.