Senior Clinical Laboratory Scientist- Reporting

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012 Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care including screening to find cancer early monitoring for recurrence in early-stage cancer and treatment selection for patients with advanced cancer. For more information visitand follow the company onLinkedInX (Twitter)andFacebook.

Position Summary:

The Senior Clinical Laboratory Scientist (CLS)is responsible forperforming high complexity laboratory testing on patient specimens performing quality control and quality assurance procedures andcomplying withall applicable localstateand federal laboratory requirements.

The nature of the work requires excellent attention to detail effective written and verbal communication skills the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

Essential Duties and Responsibilities:

• Perform laboratory testsproceduresand analyses according to the laboratorys standard operatingprocedures;
• Operatemaintainand troubleshoot equipment according to the laboratorys standard operatingprocedures;
• Review interpret and report patient results in LIMS asassigned;
• Independentlyidentifyand troubleshoot high complexity problems that adversely affect the testperformance;
• Perform review and document laboratory quality controlprocedures;
• Document all corrective actions taken when test systems deviate from the established performancespecifications;
• Perform and document routine preventivemaintenance;
• Prepare reagentsrequiredfortesting;
• Perform and document reagent qualification per the approvedprotocols;
• Leadin introduction of assay improvements new assayconfigurationsandvalidation;
• Provide direct supervision of the work of unlicensed laboratory personnel during the analytical phase oftesting;
• Communicate effectively with coworkers and non-laboratorypersonnel;
• Write and review of controlled documents asassigned;
• Lead the training ofnew and existing laboratory personnel on current and newprocedures;
• Participate in the inspection preparation activities asneeded;
• May act as a team leader/delegated General Supervisorandaid the Supervisors/Managersincluding but not limited to:
• Assistin administrative duties including but not limited to review of documents andforms;
• Take charge of shift communication if supervisors/leads are notpresent;
• Provide updates to supervisors/leadregardinganyissues;
• Assistin sample and process troubleshooting; and
• Monitoring data and process status as needed.
• Perform other laboratory duties as assigned; and
• Report all concerns of test quality and/or safety to the Laboratory Supervisor Laboratory Director or Safety Officer.

Qualifications:

• Must possess an active valid CLS or Clinical Genetic Molecular Biologist Scientist (CGMBS) license issued by the state of California CLS or CGMBS licensepursuant 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 or specialties they are performing;
• Must fulfill requirementsstatedin 42 CFR493.1489or493.1491;
• Must fulfill requirementsstatedas described in 10NYYCRRPart58-1.5;
• Must fulfill requirementsstatedin the College of American Pathologists Molecular PathologyChecklist;
• Bachelors degree or equivalent in Biomedical Laboratory Science ClinicalScienceor related fieldpreferred;
• At least two years of Guardant Health Clinical Laboratory experience or equivalent high complexity and volume laboratory experiencepreferred;
• Laboratory experience within the last yearpreferred;
• Experience in molecular biology techniquespreferred;
• Working knowledge of local state and federal laboratory regulationspreferred;
• Able to integrate and apply feedback in a professionalmanner;
• Ability to manage daily test processing needs with high emphasis onquality;
• Ability to analyze and problem solve basic issues that impact testperformance;
• Ability to work as part of ateam;
• Strong computer and automation skills; and
• Ability to proactively communicate consistently clearly and honestly.

Work Environment:

• Hours and days may vary depending on operationalneeds;
• Standing or sitting forlong periodsof time may benecessary;
• May be exposed to hazardous materials blood specimens and instruments with moving parts heating or freezing elements and high-speedcentrifugation;
• Repetitive manual pipetting may be necessary; and
• Some lifting (up to 25 pounds) may be necessary.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays Tuesdays and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.