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Clinical Laboratory Lead Technologist
Morrisville, NC 27560 United States
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's initial clinical product, FoundationOne™, is a fully informative genomic profile to identify a patient's individual molecular alterations and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.
Summary of Position
Foundation Medicine is dedicated to bringing personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine has developed clinical laboratory tests that broadly capture tumor genomic/molecular information and connects it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient. This is a diverse, fast-paced, team oriented environment integrating laboratory science, cancer genetics and genomics, process data metrics and clinical data.
Candidates should be highly motivated, confident with multi-tasking, attentive to details, have excellent organization skills, and show a history of leading high functioning teams. This position will also perform patient sample testing, equipment maintenance, solution and reagent preparation in addition to other tasks in a highly complex clinical diagnostic laboratory.
As our North Carolina facility continues to grow, we are looking for a Clinical Laboratory Lead Technologist that can flex across elements of our molecular, histology, and IHC testing processes. This candidate will support the Lab Manager in the oversight of multiple processes and ideally have broad exposure and expertise in these areas.
Shift (shift differential for eves and weekends):
• Tuesday-Friday (11am-7:30pm); Saturday (8am-4:30pm)
• Supervises day-to-day activities and workflow of the clinical histopathology laboratory and performs daily activities, as needed.
• Ensures timely completion of testing to the expected turnaround times and ensures smooth hand-offs to other shift leads.
• Supports in collecting, maintaining, and evaluating monthly metrics and inventory.
• Works with Client Services to resolve sample holds and ensures timely resolution of problem cases.
• Supervises timely maintenance of equipment and other technical resources. Collaborates with internal teams, vendors, and others as needed to resolve issues, maintain ongoing functionality, and document service/PM/repair work.
• Collaborates with other team leads/supervisors/managers in assigning work/developing rotational schedules and assigning team duties.
• Serves as back-up to Manager in reviewing and approving timecards.
• Assists in the development of competency, training and orientation of histopathology staff.
• Supports Manager in evaluating performance, providing input to reviews, corrective action and recruitment of new hires.
• Performs high complexity testing according to established SOPs
• Trains team members in laboratory functions/tasks.
• As needed, flexes to cover scheduling gaps and is included in the on-call rotation for additional weekend and/or holiday technical support.
• Participates on cross-functional teams to coordinate troubleshooting, process improvements, and/or implement new workflows or products.
• Maintains a deep understanding of laboratory processes in order to ensure effective troubleshooting of assays and instrumentation. Ensures team members also have the necessary understanding to effectively carry out these duties.
• Completes projects fitting of level of expertise and is able to deliver results with minimum guidance.
• Is a trusted team member and considered a “go-to” person to field questions about sample processing.
• Demonstrates commitment to meeting TAT objectives, quality metrics, key performance indicators, and ensuring an environment of continuous improvement.
• Reviews and writes SOPs, lab tracking forms, non-conformance reports, etc. as needed.
• Leads or coordinates reagent and assay quality control and validations as needed.
• Coordinates prospective and retrospective reagent QC to qualify reagents for use in the lab.
• Reviews data and maintains appropriate QC documentation for reagents.
• Performs routine QC of laboratory batch records.
• Proven track record working as a leader within a laboratory team
• Experience working in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH/QSR)
• Experience ensuring compliance of a clinical laboratory to regulatory standards.
• Knowledge of laboratory safety protocols
• Ability to learn new tasks in appropriate timeframes
• Possesses technical skills necessary to perform histopathology specimen receipt and triage; sectioning and staining; automated IHC and FISH, and/or
• Knowledge and experience working with DNA manipulation techniques, enzymatic reactions, and sequencing chemistry is a plus; as is familiarity with high-throughput platforms, laboratory automation, and common molecular laboratory equipment (thermocyclers, liquid handlers, etc.) Experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, SOPs)
• Experience with Laboratory Information Management System (LIMS)
• Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point
• Excellent communication skills
Education or Experience
• Minimum BS in a Biological or Life Science
• Qualifies as General Supervisor according to CAP regulations
• 5-7+ years of relevant lab experience in a CLIA/CAP/GLP lab
• HTL (ASCP) Certification or MB (ASCP) Certification obtained or eligible within 6 mos
• QSR compliant lab experience preferred but not required
Apply Here: http://www.Click2apply.net/3mh8zm75f8p4d2yx
North Carolina Biotechnology Center