Manish Kumar Garg

Distinguished pharmaceutical technology leader and researcher with over 15 years of experience in Serialization, DSCSA Compliance, and Healthcare Informatics. Currently serving as the global authority for serialization architecture at Hikma Pharmaceuticals, overseeing supply chain security across 35+ regulatory jurisdictions. A published author and editorial board veteran specializing in the integration of AI/ML within GxP-validated environments and pharmaceutical supply chains. CORE EXPERTISE Pharmaceutical Technology: Serialization (EPCIS), Track & Trace, DSCSA & Global Regulatory Compliance (U.S., EU, MENA). Healthcare Informatics: AI-driven exception management, data integrity frameworks, and "zero-lag" supply chain integration. Enterprise Systems: SAP S/4HANA, ATTP, EWM, and MDG governance within GxP environments. Research & Publication: SCI/Scopus indexed author, peer reviewer, and keynote speaker. EDITORIAL & ADVISORY EXPERIENCE Editorial Advisory Board Member | Pharmaceutical Technology Editorial Advisory Board Member | Pharma Focus America Expert Peer Reviewer | IEEE Journal of Biomedical and Health Informatics (Impact Factor: 7.0+) Expert Evaluator | IDC MarketScape 2026 & Fierce Life Sciences Innovation Awards PROFESSIONAL EXPERIENCE Hikma Pharmaceuticals (USA) | Associate Director, IT Applications | 2024 – Present Sole global authority for serialization architecture and DSCSA interoperability. Lead the NDC-12 transition project and master data overhaul for FDA compliance. Managing a team of 25+ engineers to ensure supply chain security for life-saving medicines. Previous Tenure Highlights: Intel Corporation: Strategy and project leadership within complex global ecosystems. SAP Life Sciences: Active contributor to co-innovation programs and industry standard-setting. SELECTED PUBLICATIONS & SCHOLARLY WORK “Rise of AI/ML-Powered Accelerators in Pharma Secure Supply Chain” – Pharma Focus America, Issue 07 (2026). “The AI-Synchronized CMO” – PharmTech.com (March 2026). Peer-reviewed Research – JITCAR (Taylor & Francis), Scopus Indexed. Industry Contributions – Regular technical insights for Pharma Commerce and Forbes Technology Council. HONORS & KEYNOTE ENGAGEMENTS Supply Chain Professional of the Year 2026 (Asia). Keynote Speaker: IntraLogisteX Dallas 2026 (September), SAP Innovation Day, ASUG, and IEEE Day. Professional Affiliations: IEEE Senior Member, Project Management Professional (PMP), Professional Scrum Master (PSM).