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

Role Summary

Senior leader responsible for the 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 operational technologies. The role enables secure data exchange, workflow interoperability, and validated system readiness to support external execution partners, while ensuring interoperability and ownership boundaries across internal and external environments. Based primarily in Cambridge, MA, with regular engagement at Cambridge labs and Norton/Alewife manufacturing sites and direct interaction with external partners.

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
• Build the Lab-to-Product Platform (Internal + External Execution Model)
• Architect and deliver the operational platform that connects experiment execution ‚Üí sample workflows ‚Üí QC testing ‚Üí plant operational activities ‚Üí 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, and external 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 ‚Äì including external partner-generated data ‚Äì 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

Required

• Bachelor‚Äôs 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 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

Preferred

• Advanced degree in Computer Science, Engineering, or Life Sciences
• Experience supporting RNAi, oligonucleotide, or other advanced modality development or manufacturing
• Familiarity with modern integration architectures (APIs, event-driven patterns), lab automation frameworks, OT/plant-floor technologies, and emerging AI-driven automation
• Experience in environments where R&D, CMC, QC, Manufacturing, and external partners depend on shared operational platforms and validated systems

Education

• Bachelor‚Äôs degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience)
• Advanced degree (preferred)