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Palo Alto, California, United States
Onsite
DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
In this role, you will be a member of the Laboratory Operations team with primary responsibility for equipment lifecycle management and operational support for laboratory equipment, automation hardware, and associated software used in the Clinical Laboratory. You will support equipment qualification, maintenance, calibration, service, troubleshooting, and ongoing equipment performance to ensure laboratory systems remain reliable and ready for use.
In addition to equipment responsibilities, you will support the pre-analytical and analytical phase of testing, including specimen receipt, accessioning, as well as general laboratory operations. You will work closely with Clinical Laboratory Scientists, automation, assay development, and technology transfer teams to build and maintain scalable laboratory infrastructure. As part of a cross-functional team, you will help launch and sustain clinical products designed to improve how cancer is detected and managed.
Maintain the laboratory equipment management program, including associated standard operating procedures (SOPs), processes, and documentation.
Maintain equipment inventory within the Sapio management system to ensure equipment operation, maintenance, calibration, qualification, and service records are accurate and current.
Qualify, maintain, and troubleshoot laboratory processing equipment, including but not limited to centrifuges, liquid handlers, sequencers, and associated computer hardware such as barcode scanners and printers.
Coordinate equipment installation, qualification, preventive maintenance, calibration, repairs, relocation, and decommissioning activities with Laboratory Operations, supporting departments, and equipment suppliers to minimize operational downtime.
Serve as a primary point of contact for equipment suppliers and service providers and oversee equipment service contracts and associated records.
Execute equipment qualification protocols and prepare qualification reports, calibration records, and other formal equipment documentation in support of laboratory operations and regulatory inspections.
Support the automation team needs by partnering with appropriate technical teams to investigate and resolve complex equipment-related issues.
Analyze and report equipment performance metrics and drive continuous improvement initiatives to improve equipment reliability, performance, and availability.
Support equipment and resource planning for laboratory scale-up and future capacity requirements.
Partner with supporting departments on technology transfer, implementation of new equipment and workflows, and laboratory process improvements.
Train laboratory personnel on the proper use, maintenance, and operation of new and existing laboratory equipment.
Support laboratory inventory management activities as needed, including inventory monitoring, stocking, organization, and coordination of laboratory supplies, consumables, and reagents.
Assist Clinical Laboratory Scientists with permitted pre-analytical and analytical-phase activities in accordance with approved laboratory procedures and applicable regulatory requirements.
Provide hands-on laboratory support as a Clinical Laboratory Associate, including equipment setup, reagent and consumable preparation, laboratory organization, and cleaning of labware, equipment, and work areas.
Revise laboratory operational SOPs, work instructions, and other controlled documentation as needed.
Lead and support the training of new and existing laboratory personnel on applicable procedures, including providing hands-on instruction, guidance, and feedback and ensuring required training documentation is completed.
Partner with Laboratory Operations leadership to support day-to-day laboratory coordination, including task delegation to other CLAs, team meetings and huddles, scheduling, and prioritization of laboratory activities.
Required
Associate degree or equivalent in Biological Sciences, Engineering, Laboratory Technology, or a related scientific or technical field.
At least 5 years of combined experience maintaining, servicing, and troubleshooting laboratory equipment in a regulated production or laboratory environment.
Experience supporting high-throughput production or laboratory operations.
Strong mechanical and technical aptitude with the ability to independently troubleshoot complex laboratory instrumentation and equipment issues.
Experience writing and maintaining controlled documentation, including SOPs, equipment qualification protocols, maintenance records, and other equipment lifecycle documentation.
Strong organizational and project management skills, with the ability to manage multiple equipment projects, service activities, and competing operational priorities simultaneously.
Ability to communicate technical information effectively and collaborate with cross-functional teams, equipment suppliers, and service providers.
Desire to contribute to a diverse, collaborative, and mutually respectful working environment.
Preferred
Bachelor’s degree in Biological Sciences, Engineering, Biomedical Laboratory Sciences, Clinical Laboratory Science, or a related scientific or technical field.
1+ years of Clinical Laboratory experience or equivalent high-complexity, high-volume laboratory experience.
Experience working in a regulated environment such as CLIA, CAP, NYS, FDA, ISO, and/or GxP.
Experience supporting next-generation sequencing (NGS) laboratory equipment and workflows.
Experience with liquid-handling automation, including Hamilton STAR or equivalent platforms.
Experience supporting laboratory equipment and infrastructure, including freezers, refrigerators, centrifuges, and environmental monitoring systems.
Experience with equipment qualification, calibration, preventive maintenance, service coordination, and equipment lifecycle management.
Experience in reagent manufacturing, preferably in a regulated environment such as cGMP.
Experience participating in laboratory inspections or regulatory audits.
Recent hands-on laboratory experience.
