PROFESSIONAL EXPERIENCE

SHIONOGI PHARMA, INC (previously SCIELE PHARMA, INC.), Atlanta, GA 2008 – 2011
A pharmaceutical company specializing in sales, marketing and development of branded products.
Senior Director, Project Management
Leadership position responsible for initiating and growing the maturity of project management in the organization. Responsibilities include the direct management of key strategic projects as well as supervision of Program and Project Managers that directed teams through new product commercializations, existing product optimizations, product site transfers and compliance programs. Build effective relationships with external US and European partners. Reporting to the President and Chief Operating Officer.
• Initiated cross functional teams and project management processes in support of new and existing product related projects.
• Organized a recurring reporting mechanism of project status on all projects to the Executive Team.
• Initiated corporate cultural change through project team based results driven activities, growing project management maturity.
• Achieved consistency, aggressively executed and completed projects through a team of four Project/Program Managers responsible for a portfolio of 26 projects/programs.
• Directly managed a Compliance Program with multiple projects supporting an FDA response effort.
• Facilitated the integration and further developed a combination drug/device product line that was acquired.
• Successfully directed a Strategic Project Initiative to aggressively develop and launch specific products to generate incremental revenues prior to year end.


WATSON PHARMACEUTICALS, INC (Formerly ANDRX CORPORATION), Davie, FL 2003 – 2007
A leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products.
Director, Project Management
Leadership position providing supervision of Program and Project Managers that lead cross-functional teams through new product commercializations, existing product optimizations and outsourced/site transfer products. Additionally, assumed direct management responsibility for strategically significant corporate initiatives and the development of processes in support of the Project Management Organization.
• Initiated and organized Project Management Organization in support of new and existing product projects.
• Developed and implemented a methodology for project portfolio resource management
• Directed a program of projects supporting the successful closure of quality and regulatory initiatives; initiated cultural change by holding functional heads as project owners accountable for the success of the project
• Directed an accelerated strategic program of projects supporting the re-validation of all marketed products within nine months.
• Developed a project management methodology for the consistent execution of phase-gated projects
• Directly managed multiple teams to successfully launch various high profile new products through process development, validation and product launch phases.

BOSTON SCIENTIFIC CORPORATION, Miami, FL 2002 – 2003
$3B Company focused on the development and advocacy of less-invasive medical devices and procedures
Senior Program Manager, Translute Program (part of the Taxus drug-eluting stent system)
Directed a cross-functional team to establish external dual sourcing for Translute, a novel excipient utilized on the Taxus drug-eluting stent. This included the implementation of significant short-term process capability improvements in order to support the impending OUS launch. Additionally supported the FDA submission, directed the process/product development and process validation in support of the U.S. filing and subsequent pending approval. Reported to the Vice President of Operations.
• Initiated and implemented short term objectives, pre FDA filing, to sustain continuous production and build stock at current supplier in support of OUS launch while developing secondary external source.
• Identified and organized the short term need for significant resources at external supplier in order to optimize and improve capability prior to process validation. Transition process from R&D to Operations.
• In parallel with short-term objectives, implemented longer-term objectives including retro-development efforts linking process variables with the specification, process refinement efforts to create a more robust process and test method development.


ELAN CORPORATION, Miramar, FL 2000 – 2002
$1.5B Company focused on the discovery, development and commercialization of specialty pharmaceuticals
Associate Director, Technology Transfer and Process Improvement
Managed new product transfers from development phase into operations and existing products to new strategic locations within Elan and contract manufacturers. Also focused on process improvements for existing product lines. Managed eight project managers.
• Initiated and organized startup of new department within Operations group.
• Transitioned manufacturing site to multiple product operation through scale-up and commercialization of Avinza and Ritalin LA.
• Developed and implemented operations-wide project management process inclusive of early stage development phase through launch phase.


TCPI, Pompano Beach, FL 1998 – 2000
A $6M home medical diagnostic business including brand name and OEM strip and wand related products
Director of Operations
Oversaw materials management, manufacturing, packaging, quality control and customer service.
• Improved operations by combining responsibilities to reduce costs 20% and raise skill level.
• Implemented inventory reduction plans which included consolidation from offsite facility.
• Transferred and scaled-up pregnancy test product from R&D to production.
• Initiated cost reduction program targeted at 20% through self-manufacture of key products.


HILL-ROM, Batesville, IN (A Hillenbrand Industries Company) 1997 – 1998
Leader in the worldwide health care community providing innovative patient care systems and solutions
Director, New Product Development
Directed efforts of cross-functional team to successfully develop and launch leading edge medical care product, which improved transitional care for hospital bed patients. Additionally, directly managed design-engineering group.
• Directed matrix cross-functional team consisting of operations, design, quality, regulatory, and marketing that initiated cultural change towards project teams. Implemented new product development process.
• Cut scheduled development cycle time in half through parallel and accelerated tasks.
• Implemented continuous flow work cell on existing production line through Kaizen approach.


DADE INTERNATIONAL, INC., Miami, FL 1992 – 1997
Formerly Baxter Healthcare Corp., Dade Diagnostics Division, subsequently Dade Behring, Inc.
Director, Platelet Function Analyzer Program
Directed efforts of multiple site/function teams to successfully execute business plan from early patent R&D phase through launch phase for leading edge medical diagnostic technology associated with platelet function. This $100M global business was initially launched in Europe Q2 ‘96 with US launch in Q3 ‘97. Team consisted of eight core members and support staff of twenty-five.
• Directed matrix cross-functional team that initiated team-empowered cultural change and customer-driven product design, including QFD (Quality Function Deployment) process.
• Initiated business development opportunity over and above base business plan.
• Established operations for Platelet Function Analyzer product including new facility and processes.
• Drove development and implementation of global marketing program to support execution of business plan including controlled roll out in Germany.


BAXTER HEALTHCARE CORPORATION, Valencia, CA 1989 – 1992
Pharmaseal Division
Restructuring Program Manager 1990 – 1992
Directed successful transfer and disposition of production, assembly, inventory and related facilities/equipment for seven domestic and international manufacturing plants. Prepared and executed budgets and arranged service and inventory levels to bridge transfers.
Manager o***** Facilities Engineering 1989 – 1990
Implemented new programs in Total Quality Management, Just-in-Time inventory controls and streamlining allocation of production lines. Also directed day-to-day facilities management of division headquarters with staff of fifteen (215,000 square feet on ten acres).

MBA, Northern Illinois University, DeKalb, IL
BS, Civil Engineering, University of Illinois, Urbana-Champaign, IL

Certified Project Management Professional PMP, Project Management Institute PMI
Licensed Professional Engineer, State of Illinois
Past Chair Board of Directors, New Product Development SIG, PMI