Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Manager of Histology, Clinical Operations is responsible for the technical operations of the Histology Laboratories for the TissueNext Program. The Manager monitors patient and quality control testing results, writes, and reviews standard operating procedures, addresses technical issues and takes remedial action when needed. The Manager ensures laboratory staff are correctly trained on all processes and supervises both licensed and unlicensed laboratory team members. The Manager will be responsible for supervision of the histotechnician staff. The Manager demonstrates good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure and the ability to communicate effectively across levels and functions. The Manager will ensure that the Histology Production team adheres to CLIA and CAP standards. The Manager complies with all applicable local, state and federal laboratory requirements and operates under the direction of the Laboratory Director and Senior Director of Biospecimen Management.

Essential Duties and Responsibilities:

Accurately monitor histology testing;
Conduct and oversee daily data generated during testing and generate monthly longitudinal monitoring metrics;
Lead a variety of other essential laboratory activities, including inventory management, procedure writing, inspection preparation, assay validation and investigation;
Work with the Clinical Operations, Client Services, Reporting, and Software Enterprise Departments on the laboratory’s quality control and quality assurance procedures, technical troubleshooting and improvement procedures, reagent manufacturing, and training and education programs;
Review and document routine preventive maintenance and independently identify and troubleshoot highly complex problems that adversely affect test performance;
Writes and reviews standard operating procedures, performs other administrative duties including but not limited to: writing and reviewing employee performance evaluations, protocols, clinical trial sample tracking and equipment maintenance forms
Identify root cause and document all corrective actions taken with test systems;
Oversee training and competency of new and existing laboratory personnel;
Manage stability study, validation protocols, and other process improvement and new assay projects;
Participate in audits and inspections;
May oversee the tissue biospecimen management team operations
Manages and leads department projects and goals
Perform biennial review of Standard Operating Procedures;
Participate in introduction of assay improvements, new assay configurations and validation;
May represent the Biospecimen Management and Histology Department in cross functional meetings
Support the Tissue Clinical Operations team and be responsible for the daily operations of the biospecimen management and histology laboratories including but not limited to scheduling, independently troubleshooting and resolving technical and non-technical high complexity problems;
Report all concerns of test quality and/or safety to the Senior Director, Laboratory Director or Safety Officer.

Qualifications

Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field;
Active ASCP Board of Certification in HTL required
Active license to operate as a histotechnologist in NYS
Active Qualification in Immunohistochemistry through ASCP preferred;
A minimum of 4 years of experience or equivalent in a Histology laboratory and high throughput laboratory production environment preferred;
A minimum of one year of supervisory experience is preferred;
Working knowledge of local, state, and federal laboratory regulations;
Working knowledge of FDA QSR and ISO 13485 requirements a plus;
Laboratory experience within the last year preferred;
Experience in tissue processing techniques including sectioning, slide preparation, H&E staining, macrodissection, IHC processing and troubleshooting;
Strong working knowledge of local, state, and federal laboratory regulations;
Able to integrate and apply feedback in a professional manner;
Ability to manage daily test processing needs with high emphasis on quality;
Ability to analyze and problem solve basic issues that impact test performance;
Ability to work as part of a team;
Strong computer and automation skills;
Ability to proactively communicate consistently, clearly, and honestly;
Outstanding professionalism, leadership, and communications skills;
Strong communicator with the ability to maintain open communication with internal employees, managers and customers as needed;
Ability to provide direct supervision to laboratory personnel; and
Strong project management abilities.

Work Environment:

Hours and days may vary depending on operational needs
Standing or sitting for long periods of time may be necessary
May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation (Generally Laboratory and Client Services employees only)
Some lifting (up to 25 pounds) may be necessary

Delegated Duties and Responsibilities:

Refer to assigned Delegation of Responsibilities Form

Approvals:

This job description is used as a guideline for major duties. The company reserves the right to change or assign additional duties as needed.

Additional Information

Hybrid Work Model: At Guardant Health, we have 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.

The US base salary range for this full-time position is $117,400 to $158,400. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/

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