IHC Lead Technologist

Foundation Medicine•Morrisville, NC

12d•Onsite

About The Position

The IHC Lead Technologist performs and leads day-to-day routine immunohistochemistry (IHC) testing on patient samples in a high-complexity clinical diagnostic laboratory. The role uses automated platforms to prepare samples for microscopic examination and analysis by a pathologist, and requires strong knowledge of accreditation and regulatory standards. The position supports turnaround-time objectives, quality metrics, key performance indicators, and continuous improvement. It may cover scheduling gaps and participates in an on-call rotation for additional weekend and/or holiday technical support. This is a regulated position, and regular onsite work at a designated Foundation Medicine location is an essential function. The technologist leads laboratory workflow, performs automated IHC and routine histological staining, prepares slides from paraffin blocks, and completes specimen, quality-control, validation, and documentation activities. The role maintains equipment and supplies, troubleshoots assays and instrumentation, supports staff training and competency development, and contributes to investigations, corrective actions, process improvements, and implementation of new workflows. The position also monitors operational metrics, supports CAP surveys and checklist activities, and ensures quality tissue slides and staining results are delivered to pathologists within established standards.

Requirements

Bachelor’s degree in biological or life sciences.
At least 5 years of histology laboratory work experience in a CAP/CLIA-regulated laboratory.
At least 5 years of experience working with a Dako, Leica, or Ventana autostainer.
Qualifies as a General Supervisor according to CAP regulations.
HT or HTL certification and/or ASCP Qualification in Immunohistochemistry (QIHC) is required within 6 months of hire.
Ability to work independently and collaborate with peers in a fast-paced, cross-functional environment.
Ability to use a laboratory information management system (LIMS) and MS Office, especially Excel.
Ability to work under pressure while maintaining a professional demeanor.
Ability to prioritize and thoroughly follow up on assigned tasks.
Ability to adapt to changing procedures, policies, and work environments.
Ability to perform laboratory work in the presence of chemicals and reagents and learn new tasks within appropriate timeframes.
Ability to understand and communicate scientific or technical information.
Strong written and oral communication, collaboration, and problem-solving skills.
Strong attention to detail and organizational skills.
Understanding of HIPAA and patient-data privacy.
Commitment to Foundation Medicine’s values of Integrity, Courage, and Passion.

Nice To Haves

At least 6 years of laboratory work experience in a CAP/CLIA-regulated laboratory.
At least 6 years of histology experience.
At least 6 years of experience in manual and automated immunohistochemistry testing.
Familiarity with laboratory information management systems (LIMS).
Relevant experience in a regulated laboratory environment, such as CAP/CLIA.
Basic knowledge of laboratory safety protocols.
Demonstrated experience working within tight timelines to execute project and program goals.
Demonstrated experience handling multiple tasks at once.

Responsibilities

Lead day-to-day activities and workflow of the clinical IHC laboratory.
Perform automated IHC using Dako Autostainer Link 48 and Ventana Benchmark Ultra staining systems.
Operate a microtome to produce slides from paraffin blocks.
Perform quality-control and/or verification steps for receiving and delivering specimens for IHC staining.
Perform assigned tests or test components accurately, according to the assay run schedule, within turnaround-time objectives, and in compliance with written SOPs.
Finalize test orders for delivery to the requesting pathologist.
Lead or coordinate tissue, reagent, and assay quality control and validations as needed.
Perform routine H&E staining and potentially other histological staining methods introduced over time.
Maintain sample chain of custody, including specimen handling, labeling, and batch-record preparation.
Maintain supplies and prepare reagents as required; monitor and communicate diminishing inventory needs.
Maintain an organized laboratory space and follow written SOPs for specimen handling and processing.
Troubleshoot assays and instrumentation and serve as a technical resource for problem solving and process improvement.
Identify problems that may affect test performance or reporting and take appropriate action.
Maintain and troubleshoot equipment and instrumentation; communicate repair needs to Asset Management and IHC supervisors.
Assist with staff competency development, training, and orientation, and support the department supervisor with employee-related concerns.
Communicate deficiencies involving specimens, paperwork, database information, and equipment to appropriate personnel.
Investigate root causes; write Incident/Event Reports, Non-Conformance Reports, and Corrective and Preventative Actions; and work with staff to document quality issues.
Participate in cross-functional teams addressing troubleshooting, process improvements, SOP revisions, and new workflows or products.
Assist with equipment validation, including finding cases and working through optimization, and work with outside vendors when required.
Operate and maintain IHC laboratory equipment in a clean, ready state and record and monitor required monthly logs.
Collect and publish routine processing and operational metrics and execute countermeasures to meet daily processing goals.
Ensure quality tissue specimen slides and staining results are delivered to pathologists within established quality standards.
Follow laboratory quality-control policies, including GCP, CAP/CLIA, and ISO requirements; document QC activities and recognize and correct outliers.
Oversee CAP surveys and the IHC CAP checklist.
Support laboratory supervisors with maintaining and publishing the laboratory schedule and processing metrics.
Participate in biohazard, chemical, general safety, and continuing education programs.
Receive and transmit telephone calls and emails regarding patient sample processing and resolve high-volume email inquiries.
Comply with Foundation Medicine attendance policies and perform other duties as assigned.
Cover scheduling gaps as needed and participate in the on-call rotation for additional weekend and/or holiday technical support.