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DELFI Diagnostics · 13 hours ago

Laboratory Operations Manager

Palo Alto, CA

Full-time

Onsite

Senior Level

$145K/yr - $165K/yr

6+ years exp

DELFI Diagnostics, Inc. is a pioneering company focused on the non-invasive detection of cancer through advanced technology. The Laboratory Operations Manager will lead daily laboratory operations, manage staff, and ensure compliance while performing high complexity testing for cancer detection.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical

Responsibilities

Provide day-to-day leadership/management of laboratory operations including but not limited to: leading/coaching/mentoring/managing the employees,performing patient testing, reviewing QC records, leading on Quality events, supporting the Equipment and Reagent programs, and/or monitoring the ongoing test performance indices per applicable regulatory requirements

Create, execute, develop, implement, maintain, and continuously improve the laboratory's policies, procedures, and workflow to ensure efficient operations in a compliant environment

Support cross-functional teams in implementing new products, improving processes, and troubleshooting activities. Represent the Clinical Lab department in cross-functional meetings

Participate in organizational compliance with all applicable regulatory and company procedures by providing feedback, training, and education

Perform testing and validation of new laboratory equipment and procedures. Identify and implement process improvement opportunities

Train new and existing laboratory personnel on current and new procedures

Communicate to the Laboratory Director and/or Senior Director, Laboratory Operations regarding any issues, and specimen and process troubleshooting

All other duties as assigned

Qualification

Clinical Laboratory Scientist licenseClinical Genetic Molecular Biologist licenseNext-generation sequencingMolecular biology techniquesAutomated liquid handlersLeadership experienceProcess improvementRegulatory complianceTrainingCross-functional collaborationMentoring

Required

Must possess an active and valid Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) license issued by the state of California pursuant to Division 2, Chapter 3 of the California Business and Professions Code or to practice medicine, osteopathy, or podiatry pursuant to Division 2, Chapter 5 of the California Business and Professions Code appropriate to the specialty being performed

Must fulfill requirements stated in Title 17 California Code of Regulations Section 1036.1

Must fulfill requirements stated in 42 CFR 493.1461 or 493.1462

Must fulfill requirements stated in the College of American Pathologists Molecular Pathology Checklists

Previous leadership/management experience

BS in Biomedical Laboratory Sciences, Clinical Science, or equivalent