Laboratory Operations Specialist

About the position We're seeking a Laboratory Operations Specialist with hands-on anatomic and/or molecular pathology laboratory experience to manage the operational backbone of our validation studies and AI development programs. This role focuses on tissue procurement logistics, specimen tracking, scanning operations coordination, digital pathology data management, laboratory workflow coordination, and quality management system documentation and support.

Responsibilities

• Tissue Procurement & Sample Management Coordinate tissue orders across multiple vendors
• Manage tissue sample receipt, accessioning, inventory, and storage
• Develop and maintain systems for tracking tissue blocks, slides, stains, and associated metadata
• Track chain of custody documentation and specimen traceability
• Reconcile tissue orders against invoices and study requirements
• Coordinate with histology contract labs for slide preparation
• Maintain tissue procurement budgets and vendor performance metrics
• Oversee research supply chain needs including reagents and equipment in coordination with laboratory teams
• Digital Pathology Operations & Workflow Coordination Schedule and coordinate whole slide imaging across multiple projects
• Organize and maintain digital pathology datasets, file structures, and records for AI development and validation
• Support slide scanning workflows, labeling, completeness checks, and readiness for downstream analysis
• Monitor scanner performance and coordinate technical troubleshooting
• Track scanning queues, turnaround times, and slide prioritization
• Manage digital slide file organization and pathologist delivery (SVS files)
• Maintain scanning logs and quality control documentation
• Interface with scanning facilities and equipment vendors
• Data Tracking, Documentation & QC Support Maintain detailed project trackers, timelines, and sample databases
• Create and update study-specific spreadsheets and dashboards
• Track sample consumption across validation studies and AI training projects
• Support QC workflows for digital slides and datasets, including basic quality checks, labeling accuracy, and metadata completeness
• Support documentation compilation for regulatory submissions
• Ensure data integrity and traceability for audit readiness
• Generate weekly status reports on procurement and scanning operations
• Pathologist & Vendor Coordination Coordinate pathologist case assignments, tracking review progress and ensuring deliverables are met
• Serve as primary contact for tissue vendors and contract labs
• Manage logistics with courier services for biological sample shipments
• Coordinate with external pathologists and subject matter experts on sample delivery schedules
• Support CRO coordination for validation study logistics
• Troubleshoot vendor issues and procurement delays
• Assist with vendor qualification and external partner management as needed

Requirements

• Bachelor's degree in biological sciences, medical sciences, pathology-related fields, or closely related discipline
• 3+ years in a clinical pathology laboratory environment (hospital lab, reference lab, academic pathology department, or pathology-focused CRO)
• Direct experience with tissue specimens (FFPE blocks, slides, fresh tissue, or frozen samples)
• Hands-on experience with specimen accessioning, tracking, and inventory management
• Familiarity with histology workflows (tissue processing, embedding, sectioning, staining)
• Strong organizational and project coordination skills with ability to manage multiple workflows simultaneously
• Proficiency with LIMS systems or laboratory databases
• Experience with chain of custody documentation and sample traceability
• Comfortable working with both physical biological samples and structured digital datasets
• Technical Skills: Advanced Excel skills (pivot tables, VLOOKUP, complex formulas, data validation)
• Experience managing multi-project tracking systems and databases
• Strong attention to detail and data accuracy
• Comfortable learning new laboratory systems and equipment
• Excellent written and verbal communication skills with ability to coordinate across technical teams
• Regulatory/Quality: Understanding of quality control practices in clinical laboratories
• Familiarity with CAP, CLIA, ISO, or GLP standards
• Experience supporting laboratory audits or inspections (preferred)

Nice-to-haves

• Experience with digital pathology or whole slide imaging systems (e.g., SVS files)
• Background in anatomic pathology (vs. clinical chemistry or hematology)
• Prior work in medical device, IVD, or diagnostic development
• Exposure to regulated laboratory operations or FDA submissions
• Histotechnology certification (HTL, HT(ASCP))
• Experience with immunohistochemistry (IHC) or special stains
• Familiarity with tissue microarrays (TMAs)
• Background in oncology diagnostics
• Experience coordinating cross-functional teams across scientific, technical, and operational domains
• Prior exposure to AI/ML development workflows or training dataset management

Benefits

• High-impact work: Direct contribution to breakthrough AI-powered pathology technology
• Learning opportunity: Exposure to cutting-edge digital pathology AI, regulatory processes, and startup environment
• Growth exposure: Work closely with cross-functional teams including AI/ML, clinical development, and regulatory affairs

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