Kevin Smith Email & Phone Number

Pharmaceutical Regulatory Compliance Consulting

Glen Mills, Pennsylvania

* Responsible for both the clear coat and accessory products * Serve as hub and project manager coordinating with the sales, marketing, R&D, supply chain and operations* Manage process creation and optimization projects

Conshohocken, Pa

* Responsible for the management, forecasting and reporting of ABDC’s product inventory to support the working capital initiatives* Responsible for ABDC’s annual LIFO process * Responsible for overseeing the GSMR department budget

Wilmington, De

* Responsible for the Profit and Loss for two ASI Strategic Business Units, Global Preservatives and Global Biocides which have a combined revenue of approximately $100MM with a wide range of profitability. * Collaborate with the commercial and business unit teams for costing analysis, pricing and strategy support.* Support manufacturing facilities and global technology for cost reduction initiatives and new product support.* Analyze and approve business unit products and strategies and continually rationalize the product portfolio.* Analyze and communicate strategic recommendations and business results to the ASI leadership team including new product introductions, plant consolidations, strategic alliances and product retirement.

Wilmington, De

* Owner of all Global ASI processes to support the commercial and technical sides of the business.* Lead all ASI customer aquisition initiatives.* Global business owner of Salesforce.com including design, implementation, testing and training.* Re-designed and improved the global customer sample process from >30days to 2.7 days in 4 months from initial root cause analysis through stabilized results.* Lead the implementation of SAP (GlobalOne) Recipe Management module three months ahead of schedule for a newly acquired business with no data issues.* Analyzed business data to support tactical and strategic decisions and for post mortem evaluations. * Developed and owned the CRM tool Salesforce.com for the commercial and technology teams.* Created new processes for the newly integrated ASI organization including the New/Existing Product Introduction/Change Process, alternate processes for business critical time sensitive processes, Tolling/3rd Party Manufacturing Set-up and Management, Stage Gate projects, etc. * Held various leadership roles for the AAFI/ISP integration team including ASI web site redesign, four major IT projects, leader for the specification change and new product introduction databases.

Newark, De

Production and Materials Planning Manager (PMP) for the Blister-Wallet PET * Responsible for the scheduling of production and down time events for the Blister-Wallet PET as well as for ordering components and bulk tablets from internal and external global suppliers.* Successfully planned the transfer of 50 products (including >500 new materials) from a closed site in Canada to our production site with no impact to the customer.* Personally Lead all bulk material and component ordering (over $400M) for the entire Blister-Wallet execution team for the first year of its operation.

Newark, De

* Responsible for the conversion of the AstraZeneca Newark Site operations team to a Lean and Process Centric Organization. * Applied Lean/Six Sigma tools to meet aggressive Site cost reduction goals while not compromising GMP, OSHA, DEA and EPA compliance.* Facilitated proces engineering / value stream mapping VSM events and implemented/managed improvement activities and KPIs.* Developed and implemented strategies for increasing line OEE and reducing cycle times.* Utilized Statistical Process Control (SPC) to measure operational performance and control.* Facilitated Value Stream Mapping (VSM) exercises for AstraZeneca Site operations to deliver aggressive 2007 Site finished goods inventory, cycle time, lead time, and staffing reduction goals.* Lead the AZ Newark Site to a 40% Reduction in waste in one year and 25% the following year.* Implemented 5S at the Site to enable Site reorganization and the merging of staff roles.* Developed an Asset Strategy Model for optimizing line performance and NDC cycle times (considering NDC requirements, OEE, staffing, forecasted volumes, changeover times, etc.).* Designed a pull system to synchronize manufacturing and packaging operations and to directly link them to customer demand.* Transitioned system ownership from the Lean Team to the business.

* Lead the development and execution of Sterile Process Facility (SPF) enhancement projects as well as the training, housekeeping and safety programs. * Assessed current operations for enhancement opportunities such as product yield, quality issues, and equipment needs and lead the implementation of improvement plans.* Partnered with support departments such as QA, technical services, and maintenance to develop, write and execute protocols for validation and capital improvement projects.* Trained all levels of staff and maintained training records to support FDA/OSHA audits.* Managed the sterile facility budget and successfully implemented a strategy for a 10% cost reduction.* Lead and/or actively involved in several successful improvement projects in the direct injectibles facility that focused on product quality, reduced costs and decreased release time by 35%.

Newark, De

* Lead 30 team members and scheduled tasks associated with the manufacture of direct injectibles including equipment/component preparation, aseptic filling, and packaging * Greatly involved in supporting the validation department including designing and running trials, investigating issues, writing reports and training the team on process changes* Experience working both first and second shift and understaning the opportunities and challenges that face both situations* Responsible for the sterile facility warehosue and interfacing with both the Newark Site finished goods and components warehouses as we ll as the off campus finished goods warehouse.* Responsible for operator training execution, training documentation and performance reviews.

Cherry Hill, Nj

* Created and managed a centralized document system for the control, revision, and distribution of SOPs, forms, test methods/specifications, formal policies, protocols, etc. at the Cherry Hill, NJ site* Actively served on five task force teams created to develop and enhance Quality Systems for the re-commissioning of the site.

Conshohocken, Pa

* Microbiologist supporting the production facility* Sterile environment facility, equipment and water sampling and testing* Endotoxing testing for water (LAL)* Inventory management of department supplies (plates, agar, organisms and slants)* Performed growth promotion tests to support sterile manufacturing* Trained and tested sterile production operators for gowning qualifications

Mba, Business Administration

BS Microbiology MBA

Bs, Microbiology