Senior Clinical Laboratory Associate (Contract)

DELFI Diagnostics•Palo Alto, CA

3d•Onsite

About The Position

DELFI Diagnostics is developing advanced blood-based tests to detect cancer using machine-learning methods and whole-genome sequencing data. Their platform, DELFI, focuses on fragmentomics to identify cancer through cell-free DNA fragments. Their first product, FirstLook Lung, is a screening test for individuals eligible for lung cancer screening. The company is committed to improving health outcomes globally, especially for underserved populations, by leading with science, anchoring in pragmatism, building with and for all, and prioritizing teamwork and empathy.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.