• Project lead for DSCSA Compliance Reporting on the business side,• Onboarding Trading Partners in SAP ATTP and ICH. • Developing user requirements for Trace Request and Response in the event of a suspect, illegitimate, or recall products. Work Instructions, Testing, and project management.• Client is Gilead Sciences and Asegua.

SAP ATTP 3.0 Upgrade, Implementation of Aggregation, Master Data Mgt., Axway, Agile PLM, VRS, Full testing life cycle, writing test scripts, conducting User Acceptance Testing, capturing evidence, documenting in HPALM. Brazil Traceability Reporting on business side identifying new SOP's, Work Instructions, Testing, and project management. Client is Gilead Sciences.

• Senior Serialization Consultant focused on data exchange, interoperability, VRS, and Track & Trace.• Operational support for Biogen Serialization program; SOP updates, Agile PLM, Regulatory Intel, Master Data Management, TraceLink operations, TL VRS Solution validation. • Very interested in the application of Blockchain and Digital Supply Chains for the Life Sciences industry for adding business value beyond regulatory compliance.• Enterprise System Partners has provided life sciences solutions and services to support and enhance the digital plant since 2003.We offer professional engineering & consulting services (strategy, plan, design, deploy and sustain) for manufacturing and supply chain operations in biotechnology, pharmaceutical and medical devices.We have niche expertise in Manufacturing Execution Systems (MES), Serialization and Data Analytics.In 2019, we proudly joined the Accenture family and are now part of Industry X.0. Our deep industry, process, IT and vendor knowledge, combined with Accenture’s core capabilities and digital enablers allow us to transform manufacturing and supply chain operations for pharmaceutical, biotech and medical device clients globally.

• Architecting serialization data exchanges for Sanofi's Toll Manufacturing (provisioning, commissioning, shipments). Managed end-to-end data flows ensuring interoperability for ~30 pharma companies.• Verification Router Service (VRS) for DSCSA. • Led FDA Pilot Project for Verifications by CMO on Behalf of MAH's• Hands-on experience with TraceLink, Adents PRODIGI, Oracle OPSM, and Antares Vision• Strategic and tactical consultation for Serialization• Development of the serial number verification process and ensuring regulatory compliance with DSCSA's 24 hour rule• Interpretation of serialization mandates for defining User Requirements and system architecture• Strategic management of Level 2 (site) software for Serialization• Master Data Management (Product, Customer/Partner, and Location)• AntaresVision experience (a leading solution provided in the EU)• SAP to MES integration• Blockchain technology for the pharmaceutical and biotech industry

- Sought opportunities to leverage my experience in Serialization and Master Data Management.- Had the distinction of presenting a Blockchain recommendation for applying the technology to pharmaceutical supply chains at the first-ever Pharma Blockchain Bootcamp event organized by DisruptiveRx, November 16th 2016.

Global responsibility for Product Master Data collection, managing off-shore testing and configuration resources, and developing Quarterly Configuration Plans (at mandate, site, and SKU level of detail) for Implementation Team. Coordinated resolution of Implementation issues and Business Assessment Models.

Led the management of Master Data for the Serialization program at Pfizer. This included developing both tactical and strategic IT solutions for providing the MD required by the various country-specific mandates (CN, KR, US, BR, IN) for serializing finished goods to prevent counterfeiting, diversion, theft, and ultimately ensuring patient safety for our medications. Supported implementations for packaging lines (internal and CMO's), warehouse solutions, external trading partners, healthcare providers, and GPO's to ensure inter-operability of master data. Worked with the business areas to support training and business adoption of on-going operations. Recent work activity included supervision of off-shore analysts, building interface requirements for both Product and Customer master data from SAP to TraceLink. Implemented Data Quality metrics for serialization master data to foster ownership and governance. Defined both Pfizer-specific and industry-wide requirements for TraceLink to support master data management.

- Global Master Data Mgt. Strategy & Governance including establishing and improving relevant principles, policies, and standards- Analyzing supply chains to ensure Mark-Up elimination and Cost Chains are aligned with SAP- Design and development of an integrated data management architecture- Increase awareness of master data mgt. best practices to drive improvements to business processes, analytics and MD quality. Lead Communities of Practice.- Drive consistent and effective governance for enhancements and deployment of ERP program for all SAP Material Master related processes and functionality

Six Degrees Counterfeit Prevention, LLC provides the only non-mathematical polymorphic encryption technology in the world. This will enable mass serialization for the pharmaceutical, biotech, and medical device industries, ensure brand protection, and prevent counterfeiting, providing end-to-end e-pedigree, recall control, and ensure hack-proof security for all data without requiring special hardware or readers. Additionally, the system is a micro database less technology which eliminates the need for an expensive product database by the pharma company.

• Certified Green Belt in LSS methodology.• SAP-ECC: Created the global blueprint design for Material and Batch Master Data for Merck's SAP implementation enabling "One version of the truth" with end-to-end visibility of our products.• Building an interface Schawk Digital Solutions BLUE to SAP• Designed the supply chain master data objects (Materials, BOM's, etc) for the end-to-end supply chain, including the product hierarchy, custom product attributes, and interfaces enabling all products with a common API to be managed holistically. Collaborated with Finance, Sales, Procurement, Tax, Network Planning (SAP-APO), Inter-Company, and Production Execution to finalize the design.• Successfully built, tested, and deployed SCM Master Data for three production releases of SAP-ECC• Conducted blueprinting workshops with market and Core representatives.• Designed and built SAP interface to the ORION system (Aris Global Register™ system).• Completed unit and string testing of all functional requirements. Worked on BI reporting.• Set up the Master Data Governance model for SCMgt production support.• Designed and implemented the SAP product hierarchy that enabled a true end-to-end view of all products associated with a common active pharmaceutical ingredient (API).

• Successfully managed the MMD inventory metric in 2005 resulting in a $126 million favorable variance in actual inventory compared to the Plan of $1.85 billion. • Participated in developing the vision for Merck's Lean Manufacturing future state.• Represented the business side while building the highly innovative web-based End-to-End Cycle Time reporting tool; worked closely with A&IT and GL Associates. The Team was selected as a “finalist” for the MMD 2005 OE awards (there were 15 finalists out of 79 projects). • Created and implemented a web-based “Product Franchise Reporting” (PFR) methodology utilizing COGNOS. • Core team member for MMD’s End-to-End Cycle Time Team. The team defined new business processes, new metrics, cycle time bucket ownership, and created a new web-based reporting tool. The team followed Six-Sigma methodology.

• Managed supply chains for PRIMAXIN, MEFOXIN, and CRIXIVAN. This included Profit Plan, Inventory Plan, S&OP, Cycle Time analysis, and LROP. Managed chemical allocations to ensure supply to end markets.• Developed a web-based version of Supply Chain Views to provide worldwide access to global sales, inventory, costs, and market demand pull for all of Merck's products.• Capacity modeling of ertapenem and imipenem requirements at Rahway and Cherokee to finalize site selection for bulk manufacturing.• Pioneered converting Project Outlook Long Range Operating Plans (LROP) projections into item level unit forecasts for PRIMAXIN to assess capacity utilization of the pharmaceutical sites.

• Served as the Merck Manufacturing Division (MMD) representative on the core team of the Financial Re-engineering (FRE) project due to my expertise in inventory control and supply chain management.• Developed business process blue prints in support of the Sales, Inventory, and Cost (SIC) leg of the project. Engineered data collection processes from all domestic sites for SIC. Designed and supervised development of the Inventory module reports within the Worldwide Financial Reporting System. To this day, these reports are some of the "favorites" for many MMD users.• Supervised contract employees to build the prototype version of Supply Chain Views using PRIMAXIN as the product. The prototype was so successful, additional funds were approved to turn it into a production application for all top product families.

• Worldwide Planning for the antibiotic products. Led Stonewall’s Cycle Time Team.• Operational responsibility for purchasing, planning, scheduling, and inventory mgt. for the Elkton site.• Managed the Computer Systems support department for Elkton Pharm Operations, including MRP II, LIMS, and PC support.

Worked my way through graduate school at W&M by waiting tables at the King's Arms Tavern in Colonial Williamsburg. Was promoted to Head Waiter and taught many new waiters to serve guests with colonial grace and style.

Worked in the sterile tissue culture media preparation lab at Meloy Laboratories in Springfield, VA.