Expertise

• Senior Production Professional with extensive background in the pharmaceutical and food industries.
• Experience with the planning and startup of new facilities and the shut down or relocation of existing facilities.
• Background includes Industrial Engineering process flow design, plant management, quality assurance and twenty years of international project management.
• Strong knowledge of capital estimating, cGMP analysis, process validation plus experience with Food and Drug Administration (FDA) endorsed integrated management and balanced scorecard metrics reporting.
• Recognized for building high performing, cross-functional teams with strengths in multi-cultural interpersonal communications in European and Latin American markets.

Specific Experience

• Pharmaceutical Manufacturing
• Pharmaceutical Packaging
• Industrial Engineering
• Process Flow Design
• Facility Planning and Startup
• Metrics - Scorecard (and subject topic.)

Experience

Independent Consultant, 2003 - Present

Wyeth Pharmaceuticals, Collegeville, PA, 1989 - 2003

Associate Director Quality Assurance Planning, 2001 - 2003

• Recruited by EVP to write the charter and set up a task force team to create an Integrated Management Report (IMR) combining operational and quality assurance metrics for senior management.
• The IMR was a major company commitment made to the FDA and was completed on time.
• Selected by Senior Management to generate bi-weekly quality assurance and regulatory affairs reports for top management summarizing significant achievements and risks (potential and actual) to existing and new product supply.

Associate Director Quality Assurance Administration, 1998 - 2001

• Developed and managed a program for cost containment at domestic and global quality laboratory sites.
• Directed industrial engineering studies of testing procedures at Quality Control Laboratory sites.
• Saved $5 million per year by providing a forum for cross-fertilization of approaches and new ideas.
• Initiated and managed a computer weighing system that controlled the dispensing of ingredients for drug products.
• Installed and validated computer weighing systems in England, Italy and Mexico.

Associate Director Technical Services, 1993 - 1998

• Managed a program that made assessments of new products and product changes regarding formulas, processes and cGMP requirements to promote efficient and timely implementation at manufacturing sites for the international marketplace.
• Achieved at least one new product entry and five product changes made each year.

Director Manufacturing and Engineering, (Whitehall Laboratories Division of Wyeth), 1989 - 1993

• Developed manufacturing and packaging systems for new and existing facilities.
• Performed start-up of a major tableting operation in Ireland.
• Managed the shutdown of a 200 person manufacturing facility in Germany to combine operations in Ireland and other European sites.

Schering-Plough, Kenilworth, NJ, Industrial Engineer, 1981 - 1989

• Developed manufacturing, packaging and warehouse requirements for new and existing sites.
• Completed new layouts for the Mexico and Panama sites.
• Managed cost reduction programs at assigned global manufacturing sites.
• Achieved $3 million saving each year through cross-fertilization of new ideas between sites.

Sterling Drug, 1969 - 1981

Project Manager, 1977 - 1981

• Developed manufacturing and packaging equipment needs for existing and new facilities.
• Part of a two-man team coordinating the startup of a major parenteral operation in Kansas.

Plant Manager, Glenbrook, CT, 1975 - 1977

• Managed the on-site shutdown of the 300-person Milk of Magnesia facility.

Development Engineer, 1969 - 1975

• Developed packaging and manufacturing sources of new product entries in trial, regional and national markets, interfacing closely with marketing.

General Foods Corporation, (Maxwell House Division), Hoboken, NJ, 1962 - 1969

• Chief Industrial Engineer, 1965 - 1969
• Production Department Head, 1964 - 1965
• Engineer - System Startup, 1963 - 1964
• Development Engineer, 1962 - 1963
• Member of a three-person team responsible for putting on stream a five million dollar automated green coffee handling and storage.

Honors & Publications

• Awarded "Most Creative Package" for Injectable Drugs from Food and Drug Packaging Magazine
• Served on Adjunct Faculty-Industrial Engineering, Management and Safety at FDU.

Education

• MBA Fairleigh Dickinson University, Teaneck, NJ
• B.S. Industrial Engineering, Fairleigh Dickinson University, Teaneck, NJ