Senior Director, Lab-to-Product Platform and Operations Technology

About the role

The Senior Director, Lab-to-Product Platform & Operations Technology oversees core digital platforms, services, lab computing environment, and operational technologies that power laboratory operations across Research, CMC, and Quality Control, as well as digital enablement of plant-floor (shopfloor) operational technologies (OT).

Responsibilities

• Own and operate core lab, plant, and external partner operational platforms
• Lead the digital capabilities that support lab operations across Research, CMC, and QC, including LIMS, ELN/LES, sample & inventory management, registration, lab automation enablement, instrument integration, lab computing, lab system validation, and operational data capture
• Oversee plant-floor operational technologies (OT) such as equipment/instrument connectivity, environmental and facility monitoring interfaces, materials tracking, barcode/RFID data capture, and automated data collection (excluding MES and supply chain systems)
• Enable operational technology connectivity, workflow interoperability, and validated data exchange with CROs, external research labs, development partners, contract testing labs, and external manufacturers
• Support validated data handoffs, sample/material traceability, workflow tracking, and operational interfaces across hybrid (internal + external) execution models
• Ensure reliability, compliance, validated state, lifecycle management, and service continuity across internal systems and partner-connected operational interfaces
• Oversee lab/operational system validation activities in partnership with Quality to maintain GxP compliance and data integrity across all execution environments
• Architect and deliver the operational platform that connects experiment execution → sample workflows → QC testing → plant operational activities → external execution and release workflows
• Provide reusable platform components including metadata standards, workflow modules, instrument connectors, validated integration frameworks, and operational data pipelines that external partners can adopt or interface with
• Ensure seamless interoperability with: Scientific platforms owned by ReDev Technology Manufacturing/enterprise systems owned by Manufacturing/CMC/Supply Chain Technology External research, development, QC, and manufacturing partner systems
• Establish secure, scalable, validated patterns for partner connectivity (e.g., APIs, secure file exchange, partner portals, event/data streams)
• Lead a high-performing operations-focused technology team
• Build and develop talent and capabilities across product management, engineering/architecture, lab computing support, instrument connectivity, and operational platform engineering
• Define support, governance, onboarding, and escalation models for external partners, including SLAs and service continuity plans in collaboration with ReDev and TOQ
• Drive a culture centered on operational excellence, validation rigor, compliance, accountability, and pragmatic problem-solving
• Establish standards, governance, and best practices for lab/plant operational technology, including lab system validation frameworks
• Deliver robust operational data integration
• Work closely with the Data & AI organization to ensure operational data – including external partner-generated data - is structured, contextualized, and AI-ready
• Implement consistent metadata, data capture, and validated interface practices across internal and external operations
• Enable cross-system visibility into workflows, materials, samples, and processes across internal labs, plants, and external partner networks
• Partner deeply across the enterprise and external ecosystem
• Collaborate with ReDev Technology, Manufacturing/CMC/Supply Chain Technology, Quality, Tech Operations, Data/AI, Infrastructure, and Security to ensure cohesive integration and operational excellence
• Partner with ReDev and TOQ to define and support the digital operating model for CROs, external labs, contract testing labs, and external manufacturers
• Maintain clear ownership boundaries while ensuring the operational platform enables distributed execution
• Serve as a trusted partner to scientific, operational, and quality stakeholders – internally and externally

Qualifications

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience)
• 15+ years of progressive leadership experience in laboratory informatics, scientific operations, OT/plant-floor (shop floor) automation enablement, or manufacturing operational technology in biotech/pharma
• Deep expertise with lab operations systems (e.g., LIMS, ELN/LES, sample/inventory management, workflow orchestration), lab computing environments, instrument integration, and validated interfaces
• Experience supporting operational workflows across internal and external networks, including CROs, external research labs, contract testing labs, and/or external manufacturers
• Strong understanding of GxP, Computer System Validation (CSV), data integrity, interoperability, and operational data management
• Experience leading product management and engineering/architecture teams in regulated and non-regulated environments
• Proven track record delivering enterprise-scale operational platforms with measurable impact
• Exceptional communication, influence, and stakeholder-management skills
• Ability to balance long-term strategy with pragmatic execution