President - MES Consulting
432 Leedom St., Jenkintown, PA 19046
Dedicated life science systems professional with over twenty (20) years of leadership and technical experience in operations management, project management, and all aspects of manufacturing system development life cycles. Goal-oriented professional with a commitment to continuous quality improvement and proven ability to analyze, plan, organize, and manage within complex environments. Possesses advanced skills in manufacturing execution (MES) / electronic batch record (EBR) systems, system validation, operations management, and project management to increase overall efficiency and profitability for manufacturing organizations.
Career Highlights / Accomplishments
• Successfully managed / led multiple global manufacturing execution system (MES) implementations to completion.
• Refined a new computer system validation process resulting in cost savings of over $1 million annually.
• Designed, developed, and managed a new operational control system that improved on-time delivery rates by 45 percent and generated $60 MM in additional annual revenue.
• Automated labor-intensive departmental functions resulting in cost savings of nearly $200,000 annually.
• Implemented a kanban system increasing 24-hour fulfillment rates on core brand orders from 30 to 95 percent.
Major Project Experience
• Falstaff Consulting (2005-Present) President – MES Consulting
Technical and project leadership for various customer engagements including:
• Amgen – Developed multiple MBR using Werum PAS-X MES 3.1 in addition to general support activities including system and MBR testing, training material generation, and personnel training.
• CSL Behring – Responsible for the following Werum PAS-X MES project activities: MBR development, process flow specifications, recipe specifications, integration testing, MBR testing, and Protocol development and execution.
• Pfizer – System specification and implementation of the P2C2 (PMX) manufacturing execution system (MES) as a business analyst and provided support in the development and testing of validation deliverables throughout the validation life cycle.
• Pfizer – Served as a core deployment manager providing guidance on electronic batch record design/development and acting as a liaison between the core team and three sites in the Puerto Rico region.
• Propack-Data Corporation / Rockwell Automation (2000-2005) Project Manager – Manufacturing Execution Systems
• Wyeth – Served as the vendor functional lead for the design and implementation of a global manufacturing execution system performing fit-gap analyses, functional and technical design specification, and on-site support for go-live activities.
• Abbott – Managed a multi-million dollar global implementation of a manufacturing execution system for a nutritional supplements product line.
• Hoffman La Roche – Managed a team of 15 client employees through the entire system development life cycle of a standalone labeling system. Managed the validation of a 21 CFR Part 11 and GMP compliant weigh and dispense system.
• Schering Plough – Managed the development, implementation, and validation of an HVAC/Environmental SCADA control system for a granulation suite.
• Renaissance Worldwide (1998-2000) Senior ERP Consultant
• Pepsi – Used an interactive design approach to identify the client’s current and proposed order fulfillment, production planning, purchasing, and inventory management models, performed fit/gap analyses, and defined functional and technical specifications needed to bridge these models. Designed, developed and validated numerous programs using SQL/SQR and PeopleTools to integrate legacy and standalone systems with the client’s new ERP system.
• Sara Lee / Champion Products (1993-1996) Senior Capacity Analyst / Manager Production Information Systems
• Designed, developed and validated numerous programs using SQL/SQR and PeopleTools to integrate legacy and standalone systems with the client’s new ERP system.
• Identified performance enhancement opportunities and redesigned the client’s existing work order sequencing and stock allocation procedures to reduce average cycle times on core items by 75 percent. Led to the client’s receipt of the 1995 JC Penney Industry Service Award.
• Managed labor and machine capacity planning for 8000 employees and 1500 machines across 21 internal and external manufacturing facilities increasing average internal capacity utilization rates by over 25 percent and reducing outsourcing costs by 70 percent.
• Implemented new inventory control and supply network programs reducing slow moving and obsolete inventory levels by $20 MM and decreasing average safety stock levels by 25 percent.
• Formed and managed the Planning Information Systems department, which developed internal applications, performed analyses for operations management, served as a liaison between the production planning and IS functional groups, and assisted with software training, operational and performance qualification of new applications, and joint project negotiations.
• CPIM, American Production and Inventory Control Society.
• Member of the International Society of Pharmaceutical Engineers.
• MES: Werum PAS-X, V2.3 and V3; Rockwell Automation’s PMX MES / EBR product.
• Visual Basic, Visual C++, Java2, COBOL MS Office, Paradox, Access, SQL/SQR, Oracle, and OSISoft PI.
• Certifications: CPIM (Certified in Production and Inventory Management).
• Werum PAS-X (V3) Basic Training certification.
• 20+ years experience in technical operations.
• 10+ years experience in project management.
• 15+ years experience in MES and ERP system implementation.
• 15+ years experience in computer system/process validation.
• Master of Business Administration, Operations and Supply Chain Management
o THE UNIVERSITY OF NORTH CAROLINA, Chapel Hill, NC.
o KENAN-FLAGLER BUSINESS SCHOOL.
o Member of Consulting, Operations, and Entrepreneurship Clubs.
• Bachelor of Arts in Finance and Insurance
o MICHIGAN STATE UNIVERSITY HONORS COLLEGE, East Lansing, MI.
o Dean’s Honor List. National Honor Society of Financial Management.