IHC Lead Technologist
Foundation Medicine
Summary
The IHC Lead Technologist performs and leads day-to-day routine Immunohistochemistry (IHC) testing on patient samples in a high complexity clinical diagnostic laboratory using a variety of automated platforms for microscopic examination and analysis by the Pathologist.
Job description
Key Responsibilities
- Lead day-to-day activities and workflow of the clinical IHC laboratory.
- Perform Automated Immunohistochemistry (IHC) using Dako Autostainer Link 48 and Ventana Benchmark Ultra Staining Systems.
- Operate a microtome to produce slides from paraffin blocks.
- Perform QC and/or verification steps for receiving and delivering specimens for IHC staining.
- Perform assigned tests in accordance with assay run schedule, accurately, and within TAT and in compliance with written SOPs.
- Finalize test orders to deliver to requesting pathologist.
- Lead or coordinate tissue, reagent, and assay quality control and validations as needed.
- Perform routine H&E staining with possible other histological staining methods.
- Maintain proper sample chain of custody including specimen handling, labeling, and preparation of batch records.
- Maintain adequate stock and efficient use of supplies and preparation of reagents.
- Assist in maintaining an organized lab space.
- Follow written lab Standard Operating Procedures for handling and processing of specimens.
- Maintain a deep understanding of laboratory processes to ensure effective troubleshooting of assays and instrumentation.
- Serve as a technical resource for problem solving and process improvement.
- Identify problems that may adversely affect test performance or reporting and take appropriate action.
- Maintain and troubleshoot equipment/instrumentations.
- Communicate with Asset Management team and IHC Supervisors when equipment needs repair.
- Assist in the development of competency, training, and orientation of the IHC staff.
- Support department supervisor on employee related concerns.
- Effectively communicate deficiencies to appropriate personnel.
- Investigate Root Cause Analysis (RCA), write Incident/Event Report (INC), Non-Conformance Report (NCR), and Corrective Action & Preventative Action (CAPA).
- Troubleshoot issues while working with staff to document quality issues.
- Participate on cross-functional teams to coordinate troubleshooting, process improvements, SOP revisions, and/or implement new workflows or products.
- Monitor and communicate inventory of supply and reagent needs.
- Assist with equipment validation and work with outside vendors when required.
- Operate and maintain all IHC lab equipment in proper state of readiness and cleanliness.
- Record and monitor monthly logs for all required areas.
- Collect and publish routine processing and operational metrics and execute countermeasures to ensure daily processing goals are met.
- Ensure quality tissue specimen slides and stain results are obtained and delivered to the Pathologist within established quality standards.
- Adhere to laboratory’s quality control policies (GCP, CAP/CLIA, ISO) and document all quality control activities.
- Oversee CAP surveys and CAP checklist (IHC).
- Support lab supervisors with maintaining and publishing lab schedule and/or processing metrics.
- Participate in biohazard, chemical, and general safety and continuing education programs.
- Receive and transmit telephone calls and/or emails regarding patient sample processing.
- Resolve high volume email inquiry requests.
- Perform other duties as assigned.
- Comply with FMI's attendance policies.
Basic Qualifications
- Bachelor’s degree in biological or life sciences.
- 5+ years of Histology laboratory work experience in a CAP/CLIA regulated laboratory.
- 5+ years’ experience working with Dako, Leica, or Ventana Autostainer.
- Qualifies as General Supervisor according to CAP regulations.
- Certification as a Histology Technician (HT) or Histology Technologist (HTL), and/or Qualification in Immunohistochemistry (QIHC) from the American Society Clinical Pathology (ASCP) certification is required within 6 months of hire.
Preferred Qualifications
- 6+ years of laboratory work experience in a CAP/CLIA regulated lab.
- 6+ years of experience in Histology.
- 6+ years of experience in Immunohistochemistry testing (manual and automated).
- 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 for successful execution of project and program goals.
- Demonstrated experience handling multiple tasks at once.
- Ability to work independently as well as collaborate with peers in a fast-paced and cross-functional environment.
- Utilize a laboratory information management system (LIMS, MS Office esp. Excel).
- Work well under pressure while maintaining a professional demeanor.
- Prioritize and thoroughly follow up on assigned tasks.
- Adapt to changing procedures, policies and work environment.
- Perform work in a lab environment in the presence of chemicals and reagents.
- Learn new tasks in appropriate timeframes.
- Understand and communicate scientific or technical information.
- Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving.
- Demonstrated attention to detail and strong organizational skills.
- Understanding of HIPAA and the importance of patient data privacy.
- Commitment to reflect FMI’s values: Integrity, Courage, and Passion.
Requirements
- Bachelor’s degree in biological or life sciences
- 5+ years of Histology laboratory work experience in a CAP/CLIA regulated laboratory
- 5+ years’ experience working with Dako, Leica, or Ventana Autostainer
- Qualifies as General Supervisor according to CAP regulations
- Certification as a Histology Technician (HT) or Histology Technologist (HTL), and/or Qualification in Immunohistochemistry (QIHC) from the American Society Clinical Pathology (ASCP) certification is required within 6 months of hire
Benefits
- Health Insurance
- Annual Bonus
Company overview
Foundation Medicine is a leading precision medicine company headquartered in Boston, Massachusetts, that specializes in developing and commercializing comprehensive genomic profiling assays for cancer diagnosis and treatment. Founded in 2010 as a spin-off from the Broad Institute, the company leverages next-generation sequencing technology to provide molecular information that helps guide personalized cancer therapy decisions. As a subsidiary of Roche since 2018, Foundation Medicine offers a portfolio of diagnostic tests including FoundationOne CDx, FoundationOne Liquid, and FoundationOne Heme, which analyze solid tumors, hematologic malignancies, and sarcomas. The company's mission is to transform cancer care by delivering high-quality biomarker testing throughout a patient's journey, from initial diagnosis to ongoing management. With over 1,000 employees and operations in Boston, North Carolina, and Germany, Foundation Medicine collaborates extensively with biopharmaceutical partners to accelerate drug development and advance cancer research through its extensive genomic database containing profiles from more than 300,000 patients.