Director – Clinical Lab Automation and Robotics

The Director – Clinical Lab Automation and Robotics is responsible for the strategic planning, deployment, and optimization of automation and robotic solutions across clinical laboratory operations. This leadership role ensures that automation initiatives improve accuracy, throughput, efficiency, and regulatory compliance within high-volume diagnostic and research labs. The Director will oversee a multidisciplinary team and work closely with lab managers, IT, and quality teams to standardize and modernize automation infrastructure.

Key Responsibilities:

• Develop and implement a comprehensive automation and robotics strategy across clinical lab workflows (pre-analytical, analytical, post-analytical).

• Lead design, validation, and deployment of automated sample handling, processing, and diagnostic systems.

• Integrate automation platforms with LIS, LIMS, middleware, and analytics systems to ensure seamless data and workflow execution.

• Oversee the selection and lifecycle management of robotic systems, including TLA (Total Laboratory Automation), liquid handlers, and conveyor systems.

• Collaborate with laboratory leadership to optimize lab layout and robotic configurations for operational flow and safety.

• Ensure compliance with CAP, CLIA, FDA, and ISO 15189 for all automation-related processes.

• Establish performance metrics and drive continuous improvement in lab efficiency, error reduction, and turnaround times.

• Build and lead a team of automation engineers, validation specialists, and technical support staff.

• Manage vendor relationships and service contracts for automation equipment and software.

• Stay ahead of trends in smart lab technologies, AI-enhanced robotics, and IoT integration.

Key Focus Areas:

1. Clinical Lab Automation Strategy

   • Define and lead automation roadmap aligned with diagnostic throughput and scalability needs

   • Support both high-volume core labs and specialty lab workflows

2. Robotics System Integration & Optimization

   • Oversee integration of robotic arms, conveyors, pick-and-place systems, centrifuges, decappers, and aliquoters

   • Customize automation platforms to support diverse assay types and instruments

3. System Interfacing and Digital Workflow

   • Ensure robust interfacing with LIS/LIMS, analyzers, middleware, and data reporting systems

   • Support barcode tracking, sample chain of custody, and automated result validation

4. Regulatory Compliance & Validation

   • Lead IQ/OQ/PQ, risk assessments, and SOP development for all automation platforms

   • Maintain audit-readiness and traceability documentation

5. Lean Lab Operations & Process Innovation

   • Apply lean/six sigma principles to optimize layout, material flow, and robot utilization

   • Pilot and scale novel automation solutions in collaboration with R&D and IT teams

6. Vendor and Stakeholder Management

   • Oversee RFPs, CAPEX planning, and SLA enforcement for automation-related vendors

   • Collaborate cross-functionally with IT, clinical lab leads, and regulatory affairs

Qualifications:

• Education:

  • Bachelor's or Master’s in Biomedical Engineering, Automation, Clinical Laboratory Science, Robotics, or related field

  • Advanced degree (MS, MBA, or Ph.D.) preferred

• Experience:

  • 10+ years of experience in clinical or diagnostic lab automation

  • At least 5 years in a leadership role managing complex lab automation or engineering teams

  • Proven experience with implementation of TLA systems (e.g., Siemens Aptio, Roche cobas, Abbott Alinity, etc.)

• Technical Skills:

  • Strong understanding of:

    • Clinical analyzers and automated sample preparation systems

    • LIS/LIMS platforms (e.g., Epic Beaker, Sunquest, LabWare)

    • Robotics programming and system integration

    • Regulatory standards (CLIA, CAP, FDA, ISO)

• Soft Skills:

  • Project leadership, strategic thinking, cross-functional collaboration

  • Excellent communication, vendor negotiation, and change management abilities