David Colombo Email & Phone Number

Toronto, On, Ca

Provide functional and technical support to clients in the pharmaceutical and medical device industries. Focus area is on product coding and serialization, including supply chain execution processes, IT architecture, quality system, change management, vendor management, external regulatory monitoring & assessment, and post-implementation opportunities that offer additional value.

Indianapolis, Indiana, Us

Support Lilly sales affiliates globally with improvements to coding and serialization of medicines in response to both regulatory requirements and marketplace requests.Lead the commercial implementation of serialization and improved coding solutions on over 2,000 Lilly products in over 25 markets, effectively influencing and collaborating with regulatory functions and external agencies, manufacturing and supply chain teams, and country-level sales affiliates.Serve as thought leader and active participant in various industry organizations such as PhRMA, EFPIA, GS1, Rx360, PDSA, and others.Seek opportunities for deriving additional value from serialization / product traceability in addition to compliance with regulations.

Indianapolis, Indiana, Us

Currently leading a talented, cross functional team to successfully develop, deploy, maintain, and supportpharmaceutical product serialization solutions at 8 plant sites in 6 countries, as part of anti-diversion, anti-counterfeiting, and track & trace initiatives. Leverage expertise in product serialization, IT architecture, anddistribution/logistics to provide solutions at both the enterprise and site levels that promote patient safety and protectbrand identity. Collaborate with packaging sites and sales affiliates to build organizational capability for managing newprocesses and the granular data offered from serializing product. Maintain strong external network through activeparticipation in various industry and technical forums. Leverage awareness of global legislative landscape, knowledgeof product portfolio, and deep understanding supply and distribution chains in order to set strategy and scope for theprogram. Manage budget of over $45MM with preparation to seek additional funding of over $70MM. Implement newapplications and processes that derive additional value from serialization beyond regulatory compliance.

Indianapolis, Indiana, Us

Lead and coordinate cross functional teams to successfully develop and deploy the capability to serialize finished product and manage the serialization data throughout the enterprise, as part of anti-diversion, anti-counterfeiting, bedside scanning, and track & trace initiatives. Leverage expertise in product serialization, IT architecture, and distribution/logistics to provide solutions that provide patient safety and protect brand identity. Maintain awareness of global legislative landscape in order to set strategy and scope for program. Define program strategy as input to business and operations planning. Propose applications of the solution to other areas of the business that create additional value for the customer and the brand. Collaborate with product brand leadership and sales/marketing teams to provide "more than medicine" to patients and health care providers.

Indianapolis, Indiana, Us

Led a dynamic and diverse team of customer service, import/export, and distribution operations personnel to plan and execute the supply of clinical trial medicines to over 10,000 U.S./Puerto Rico clinical sites and over 20 Lilly affiliates (countries) globally. Sponsored efforts to support cold chain distribution, including container technologies, measurement devices, and supporting IT infrastructure. Successfully leveraged information available through ERP, MES, and WMS/TMS systems to drive improvements in cycle time reduction, cost reduction, inventory / order accuracy, and forward/reverse logistics processes. Drove integration improvements across medical platforms such as IVR (Interactive Voice Recognition) and CRM (Customer Relationship Management) systems to more dynamically and effectively manage the clinical supply chain. Instilled a culture of excellence, quality, safety, and urgency through effective leadership.

Indianapolis, Indiana, Us

Led a dynamic and diverse team of customer service, import/export, and distribution operations personnel to plan andexecute the supply of clinical trial medicines to over 10,000 U.S./Puerto Rico clinical sites and over 20 Lilly affiliates(countries) globally. Championed cold chain distribution improvements, including container technologies,measurement devices, and supporting IT infrastructure. Successfully leveraged information available through ERP,MES, and WMS/TMS systems to drive improvements in cycle time reduction, cost reduction, inventory / orderaccuracy, and forward/reverse logistics processes. Drove integration improvements across medical platforms such asIVR (Interactive Voice Recognition) and CRM (Customer Relationship Management) systems to more dynamically andeffectively manage the clinical supply chain. Implemented an integrated Clinical Trial Order Management andWarehouse Management System at Lilly Clinical Trials Distribution facilities in Plainfield, Indiana; Brussels, Belgium;and Sydney, Australia. Instilled a culture of excellence, quality, safety, and urgency through effective leadership.

Indianapolis, Indiana, Us

Led the strategic design and implementation of an IT solution and complementary procedures/training for warehouse management and inventory execution functionality; This included all processes related to the receipt, storage, sampling, cycle counting, replenishment, and movement of materials to support manufacturing and packaging operations, as well as all pick/pack/ship processes for distribution of semi-finished and finished goods.Developed "Best Practices" white paper for warehousing and distribution operations, including performance metrics by functional area; Document was widely recognized and accepted as the standard means for measuring operational effectiveness throughout the enterprise.Implemented and supported warehouse management solutions at the following sites

Indianapolis, Indiana, Us

Led the strategic design and implementation of an IT solution and complementary procedures/training for warehousemanagement and inventory execution functionality; This included all processes related to the receipt, storage,sampling, cycle counting, replenishment, and movement of materials to support manufacturing and packagingoperations, as well as all pick/pack/ship processes for distribution of semi-finished and finished goods.Developed “Best Practices” white paper for warehousing and distribution operations, including performance metrics byfunctional area; Document was widely recognized and accepted as the standard means for measuring operationaleffectiveness throughout the enterprise.Implemented and supported warehouse management and chemical dispensing solutions at the following sites:o Indianapolis, IN Materials Center - 2001o Alcobendas, Spain Affiliate Distribution Automation Project - 2001o Basingstoke, UK Plant Site and Affiliate Distribution – 2002 – Re-located to UK for 14 months

Indianapolis, Indiana, Us

Led various warehouse/distribution projects, including the design and implementation of a WMS and conveyor system for the domestic and international distribution of commercial pharmaceutical product, resulting in significant quality and productivity improvements (1995)IT / SOFTWARE EXPERIENCEMS Office (Word, Excel, PowerPoint, Visio, Access); SAP (IM, WM, SD, QM, PP-PI), WMS Systems (Catalyst, HighJump, MARC); Oracle Database - SQL Plus

Indianapolis, Indiana, Us

Led various warehouse/distribution projects, including the design and implementation of a WMS and conveyor systemfor the domestic and international distribution of commercial pharmaceutical product, resulting in significant qualityand productivity improvements (1995)

Masters, Business

Bs, Industrial Engineering