Agenda Package - 02-02-09 - Laserfiche WebLink

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G 35 `Nyeth Vaccines, continued • Sr. Project Manager II October2002- August 2005 • Commissioning, Validation and ETOP Program and Project Manager for 200M plus Vaccine Facility start-up. • Develop plans and or sub-program schedules that will minimize overall launch timelines, costs and PAI submission timelines. • Monitor and report on changes in operational parameters that will impact schedule. • Lead and conduct Issue Resolution meetings to ensure schedule attainment. • Track sub-program progress activities against baseline schedule and report monthly for capital projects. • Manage and coordinate cross-site activities for commercial supply bases, long lead business, product and capital projects to ensure successful execution of master plans. New Product Planner Sept- 2001 - October2002 • Coordinate, execute and oversee all tactical activities for the implementation of new products (FluMist) into operational areas. • Interact with Third Party Manufacturer for development of forecasts and production plans for new products (FluMist). • Develop and Implement all supply chain programs for new products in accordance with cGMP inventory systems that include: Manufacturing and Production plans, BOM's, and SAP. • Perform operations project management for Tech Transfer teams. • Work with Quality Assurance, the Sustainable Compliance Initiative Team, Technical Services, Manufacturing, Purchasing, as well as Planning to meet established objectives. • Develop modeling for manufacturing scenarios. • Organize and prioritize task and schedules for supply chain teams. • Provide new product strategic planning scenarios for Senior Plant and Divisional Management. BioGaia Biologics, Inc., Raleigh, North Carolina • U.S. Director of Market Research • Responsible for conducting Market Research Trials • Development and Implementation of marketing plan for Animal Health products June 2001- August 2001 • Embrex Inc., Research Triangle Park, North Carolina September 1993- October 2000 • International Installation and Training of INOVOJECT'a Equipment and Operations. • Audit Performance of INOVOJECT® Operators and Equipment. • Preparation of Technical Maintenance Manuals. • Train North America Sales and Marketing New Hires in Operation and Maintenance of fN0VOJECf° Process and Equipment. • Environmental Monitoring of Facilities and Equipment. (Microbiological Sampling) • Site Survey Audits. • BioProcess Training in Vaccine Preparation/Administration while maintaining sterility. • Project Application Reviewer for IACUC. Global Support Training Team Sept. 1999 - October 2000 Process Development Specialist II January 1999 - September 1999 • Provided technical expertise to support the commercial application of INOVOJECT`v equipment on a global basis. • Quality Assurance of mechanical and process changes through testing and evaluation. • Obtained marketing data and supported global operations_ • Designed and participated in collaborative developmental studies with other departments, external scientists and customers. • Reported on experimental design, conducted and monitored quality assurance in laboratory and field settings. • Assisted with construction and testing of Biotechnological Equipment. Timothy Shaw Sloan