Designing and implementing AI-enabled, compliant digital platforms to keep biotech manufacturing resilient, audit-ready, and scalable.
Helping turn regulated technology environments into scalable digital platforms for life sciences manufacturing. Bridging executive strategy with engineering execution across hybrid cloud, AI, and IT/OT ecosystems in GxP environments.
Experience across R&D and MFG technology in regulated biotech environments, leading global IT/OT teams supporting GMP operations.
Designing Retrieval-Augmented Generation (RAG) systems, GenAI governance frameworks, and AI-enabled operational dashboards that improve decision-making, automate document workflows, and maintain strict GxP compliance.
Integrating manufacturing, laboratory, and enterprise technology ecosystems. Aligning MES, LIMS, QMS, historians, automation platforms, and enterprise infrastructure to enable secure, resilient, and compliant operations across hybrid environments (AWS, VMware).
Helped lead the infrastructure supporting GMP production and laboratory systems across multiple manufacturing data centers with high availability.
Real-world applications showcasing digital transformation in manufacturing and operations. Each initiative bridges strategy, compliance, and engineering execution.
Real-time operations Safety, Quality, Delivery, Cost & Involvement.
Web-based dashboard that consolidates operational status, +QDCE metrics, and exceptions into a single view so Ops, QA, Engineering and Leadership can react faster and reduce downtime.
Compliant AI assistant for SOP/Deviations writing & Policy lookup.
Retrieval-augmented (RAG) assistant enabling natural language queries against controlled SOP libraries, returning highly-traceable, sourced answers designed specifically for GMP environments.
Dual-role checklist portal for IT & scientists to go live together.
Shared onboarding tracker that assigns tasks by role — IT or Scientist — and blocks go-live until every required item is signed off on both sides. Eliminates stalled email threads, missed cybersecurity reviews, and premature instrument activation.
Self-service financial insights for operations.
Interactive hub bringing OPEX, CAPEX, and vendor spend together to give operational leaders a real-time view of budget vs. actuals — avoiding manual spreadsheet overhead.
ConfigTrace — a live demonstration of how configuration traceability is brought into a GxP-compliant environment. Connecting systems, surfacing gaps, and keeping audit trails intact without the manual overhead.
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