Laboratory Manager, Histology

We are seeking an experienced Histology Manager with a demonstrated ability to effectively lead and oversee all aspects of histology laboratory operations within a Medical Device Pathology Department in Fort Collins, CO. Responsible for ensuring the timely and accurate delivery of high-quality histological slides and data by managing a broad range of complex procedures, including both paraffin and plastic tissue processing. Operates within a highly regulated environment, ensuring full compliance with Good Laboratory Practice (GLP) standards and all applicable local, federal, and international regulations. Adept at optimizing workflows, managing cross-functional teams, and maintaining rigorous quality control to support preclinical research and regulatory submissions.

Key Accountabilities

• Provide oversight of overall histology laboratory operations for the Medical Device Pathology Department to ensure the on-time delivery of high-quality slides and/or data in a regulatory environment.
• Oversee and coordinate all histology laboratory activities, including study timelines, equipment maintenance, protocol/Standard Operating Procedures (SOPs) reviews, and ordering of chemicals/reagents.
• Maintain full visibility into the status of all histology study activities and communicate any potential impacts to established timelines to the appropriate individuals.
• Ensure that all study conduct complies with the study protocol, SOPs, and all applicable local, federal, and international regulations, including GLP.
• Stay informed of updates or changes in regulatory guidance and collaborate with Quality Assurance to address any identified deficiencies.
• Actively and effectively communicate with all stakeholders involved in histology laboratory activities (e.g., Study Pathologists, Study Directors, Quality Assurance, upper management, staff, other test sites, contractors, and clients).
• Ensure laboratory equipment is well maintained (i.e., preventive, routine, and non-routine maintenance) and appropriately calibrated, as necessary.
• Perform equipment/software qualification and/or validation, as needed.
• Oversee and assist, in conjunction with the Study Director, Study Pathologist, and/or Sponsor, with tissue trimming.
• Oversee paraffin and plastic processing, slide generation, cytochemical staining (e.g., hematoxylin and eosin, Masson’s Trichrome), and immunohistochemistry (IHC) staining, as needed.
• Collaborate with Study Directors, Study Pathologists, Principal Investigators, Sponsors, and/or other test sites to achieve specific analytical endpoints (e.g., micro-CT, SEM, mechanical testing), while developing strategies to minimize impacts on tissue quality for other endpoints (e.g., histology).
• When an untested device is to be histologically processed, work with the Sponsor, Study Director, and Study Pathologist to conduct a pilot study to determine the optimal processing method prior to full study implementation.
• Handle and ship tissue samples in compliance with regulations governing the shipment of biohazardous materials, as required.
• Directly supervise up to five staff members, including Histology Technicians and other Laboratory Support Staff, as applicable.
• Ensure histology staff are properly trained and that their training records are up to date. Training must include, at a minimum:
  • Specialized histological procedures (e.g., frozen sections, plastics processing)
  • Laboratory safety (e.g., chemical hazards, waste management)
  • Proper use of personal protective equipment (PPE)
• Hold staff accountable for meeting deadlines, maintaining quality control (QC), and overall work performance.
• Conduct staff performance evaluations and recommend merit increases, as appropriate.
• Participate in interviewing and hiring of technical staff.
• Monitor laboratory expenses (e.g., wages, equipment, supplies, and maintenance/repair costs).
• Monitor daily laboratory equipment conditions (e.g., temperature ranges for ovens, refrigerators, and freezers).
• Contribute to the development of new assays, methods, and processes, and propose innovative, well-reasoned solutions to complex problems.
• Delegate laboratory responsibilities, as needed.

Other

• Follows all SOPs and other applicable laboratory or company policies and procedures.
• Maintains confidential information.
• Supports and participates in company initiatives as directed.

• Performs periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs. Participates in SOP writing, review, and revision, as needed.
• Completes training requirements as assigned and maintains appropriate training documentation.  
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