Guardant Health - New York, NY

posted 29 days ago

Full-time - Manager
Hybrid - New York, NY
Ambulatory Health Care Services

About the position

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. 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.

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
  • Write and review standard operating procedures, perform 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
  • Manage and lead 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

Requirements

  • Bachelor's degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field, with a active license to operate as a Histotechnologist (HLT) in NYS
  • Active Qualification in Immunohistochemistry through ASCP preferred
  • Active ASCP Board of Certification in HTL 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
  • Strong project management abilities

Benefits

  • Hybrid Work Model
  • Base salary range of $117,400 to $158,400
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