Garry O.

About Garry O.

Interests: Data Analytics, mRNA, Genetics, Genomics, GxP, Pharma, Biotech, LifeScience, AI, Automation, MLSUMMARYInfrastructure Technical Lead with a proven track record of successfully implementing and managing hybrid cloud infrastructures. Extensive experience deploying high-performance IT solutions with strict adherence to regulatory compliance standards across biotech, financial, and regulated manufacturing sectors. Passionate about implementing AI and Large Language Model (LLM) projects.Core Competencies: • Technical Leadership, Project Management, Mentorship, Vendor Management • Cloud Operations and Cost Optimization • Architecture and Deployment of New GxP Manufacturing Sites • FDA GxP Qualification and Validation Processes (IQ, OQ, PQ, PPQ, DP) • Enterprise Compute and Storage Solutions • High-Performance Computing Solutions • Data Analytics and AI Integration • Disaster Recovery and Business Continuity Planning • Regulatory Compliance (HIPAA, FDA, EMA, MHRA)Technical Skills:Proficient in AWS, Azure, GCP, VMware, Cisco UCS, and various storage solutions (Pure Storage, EMC, HPE, NetApp). Skilled in Cisco networking and monitoring/security platforms including Dynatrace, Splunk, CyberArk, and OKTA. Experienced in documentation and knowledge management tools including WIKI, ServiceNow, and Veeva. Proficient with analytics toolsSummary:• Architecture and deployment of resilient GmP/GxP/Clinical/ Manufacturing BioTech sites • High-performance IT solutions for Healthcare, Financials, and LifeScience • AWS, GCP and Azure centric cloud technologies - IaaS, SaaS• Enterprise Compute: AWS, GCP, Azure, VMware, Cisco UCS and UCS-X• Enterprise Storage: Pure Storage, EMC, HPE, HDS, NetApp, AWS, WEKA HPC• Networking and SAN: Cisco, Brocade, FCoE, FC, InfiniBand, NVMe over Fabrics• Support GxP processes: Tundra Cryo-TEM, LIMS, VEEVA, Emerson DeltaV, Syncade (MES)• Enterprise Identity management: MS AD, AWS IAM, OKTA, CyberArk• Enterprise Monitoring: Dynatrace, Splunk, CloudWatch• HIPAA, GxP, GMP - IT Security and Compliance• Enterprise Disaster Recovery and BC: on-prem and cloud• Data Analytics: R, Python, Tableau, DataRobot, Julius.ai, Kaggle, ChatGPT prompt engineering

Experience

1. Hyper-scale Compute & Storage Architect

   Moderna

   Jan 2021 — Present

   Biology is the foundation of our world, and once we truly understand it, it transforms into technology.” – Ryan BethencourtI lead and mentor a high-performing, global Digital team responsible for budgeting, strategic planning, and operational excellence across GxP Manufacturing and Clinical sites in the US, Canada, EU, UK, Japan, and Australia.Responsibilities & AchievementsCompliance & Validation: Lead FDA-aligned infrastructure GxP qualification and validation efforts, including IQ, OQ, PQ, PPQ, water runs, and Veeva implementation, ensuring full compliance with regulatory standards.Global Site Deployment: Successfully deployed and qualified infrastructure for key global sites—each exceeding sq ft—including- Laval, Canada: Drug manufacturing facility via joint venture between Moderna and the Canadian government- Melbourne, Australia: GxP manufacturing plant established with the Australian government- Harwell, UK (Oxford): GxP clinical labs and drug manufacturing site in partnership with the UK government- Madrid, Spain: GxP manufacturing site established with the Spanish government- Waltham, MA (USA): Process Chemistry and Kilo Lab infrastructure for Moderna.Clinical Trial Enablement: Delivered validated infrastructure to support the Merck-Moderna Phase 3 study (V940/mRNA-4157) in combination with KEYTRUDA® for adjuvant treatment of resected high-risk Stage IIB–IV Melanoma.Regulatory Response & Audit Readiness: Numerous CAPA and risk remidiation, ensuring timely regulatory compliance.AI & Emerging Tech Leadership: Lead infrastructure projects supporting AI and data science teams, enabling innovative research and analysis pipelines.Strategic Budget & Vendor Management: Manage annual budgets up to $25 million, overseeing vendor relationships, contractors, and third-party engagements to ensure service quality, compliance, and efficiency.

Education

• Harvard Medical School

  Genetics

• Harvard Business School

  Business Analitics, AI and Machine Leaarning

• Carnegie Mellon University

  AI Academy

• HMX – Harvard Medical School

  Biochemistry

• Massachusetts Institute of Technology

  Artificial Intelligence: Implications for Business Strategy

• Moscow State University of Applied Biotechnology (MSUAB)

  Mechanical Engineering

• HMX – Harvard Medical School

  Immunology

Skills

• Enterprise Storage
• Emc
• San
• Vmax
• Hds
• Brocade
• Cisco
• Vmware
• Vce
• Storage Virtualization
• Fc
• Data Center
• Replication
• Storage Consolidation
• Fiber
• Virtualization
• Data Migration
• Fcoe
• Nas
• Symmetrix
• Emc Storage
• Epic Systems
• Emr
• Isilon
• Cisco Ucs
• Storage Area Networks
• Fibre Channel
• Cluster
• Storage Architecture
• Netbackup
• Backup Solutions
• Aix
• Business Continuity
• Solaris
• Infrastructure
• Hardware
• Tsm
• Sun
• Microsoft Exchange
• Operating Systems