Lead Histology Technician

Inotiv•Gaithersburg, MD

4d•$34 - $52

About The Position

The Lead Histology Technician independently performs advanced plastic histology activities in support of non-clinical studies, including tissue trimming, processing, plastic infiltration and embedding, block trimming, block sectioning on band saw, block and slide grinding, plastic slide generation, staining, and comprehensive slide quality control assessment, as applicable. The histology laboratory supports both paraffin and plastic resin embedding workflows, and this role is expected to routinely perform and provide technical expertise across both areas with specialty knowledge in the advanced plastic histology techniques of methyl methacrylate (MMA) and Spurr resins. Other duties may include paraffin processing, embedding, microtomy, slide staining, and quality control. Additionally, the ability to troubleshoot plastic histology techniques and to modify procedures for advances in innovation and new techniques is essential to this role. This role functions with a high degree of independence and technical discretion, executing assigned histology activities within their area of expertise with minimal oversight. The Lead Histology Technician is accountable for maintaining high standards of quality, accuracy, and consistency while ensuring alignment with study protocols, timelines, and laboratory best practices. Beyond core laboratory responsibilities, this role serves as a subject matter expert in paraffin and plastic histology techniques. The specialist provides technical leadership through staff training and mentoring and contributes to method development, optimization, and workflow improvements. This role collaborates cross-functionally with internal departments and across multiple sites and maintains a dotted-line relationship with pathology and necropsy teams. When required, the specialist may engage directly with clients or internal stakeholders to address complex technical questions or provide expert consultation. This description is intended to convey the general scope and level of responsibilities associated with the position and is not intended to be an exhaustive list of all duties, responsibilities, or requirements.

Requirements

High School Diploma.
Candidates must have a minimum of ten (10) years of hands-on histology experience, including plastic histology (methyl methacrylate and Spurr), in support of non-clinical or research studies within a regulated laboratory environment.
Demonstrated expertise in plastic histology (tissue trimming, processing, infiltrating, embedding, block sectioning, grinding, slide generation, special staining, and quality control).
Proven ability to work independently with minimal supervision, exercising sound technical judgment and attention to detail.
Strong working knowledge of Standard Operating Procedures (SOPs) and Good Laboratory Practice (GLP), including 21 CFR Part 58.
Ability to train, mentor, and support competency development of laboratory staff.

Nice To Haves

Certified Histology Technician HT or HTL(ASCP), ASCP board certified eligible, Bachelor’s degree or higher in Histotechnology, Life Sciences, or a related field.
10+ years of advanced histology experience, including plastic/resin embedding and complex staining techniques.
Prior experience serving as a subject matter expert or technical lead within a histology or pathology laboratory.
Experience with method development, validation, or optimization in a regulated research environment.
Experience supporting necropsy activities and collaborating closely with pathology teams.
Experience in client-facing or cross-site collaborative roles within CRO or industry settings.

Responsibilities

Independently perform advanced histology activities in support of non-clinical studies, including tissue processing, embedding (paraffin and plastic), microtomy, staining (special stains and immunohistochemistry, as applicable), slide preparation, and quality assessment.
Apply expert technical judgment to evaluate tissue blocks and slides, ensuring appropriate anatomical representation and adherence to laboratory and study requirements.
Serve as a subject matter expert in plastic histology techniques, providing technical guidance, troubleshooting, and consultation to laboratory staff and cross-functional partners.
Train, mentor, and assess competency of staff in histology methods; document and maintain all required GLP and process training records, including current curriculum vitae and training files.
Lead or contribute to method development, optimization, and workflow improvement initiatives to enhance efficiency, quality, and reproducibility of histology operations.
Lead the development and maintenance of training materials to enable effective cross-training and technical competency within the histology department.
Accurately document and maintain study records and data in compliance with SOPs, Good Laboratory Practice (21 CFR Part 58), and applicable regulatory requirements.
Utilize laboratory and business computer systems (e.g., Microsoft® Excel, Word, Outlook) for documentation, data review, and communication.
Perform additional duties as required to support laboratory operations, study objectives, and organizational goals.