Consultant in International Pharmaceutical Processing, Production, Manufacturing, Packaging, and Facility Design, Relocation, Startup and Shutdown (1164)
Expertise
Senior production professional in pharmaceutical and food industries.
Planning and startup of new facilities and the shut down or relocation of existing facilities.
Industrial engineering process flow design, plant management, quality assurance and international project management.
Automated weighting systems for filling and packaging.
Capital estimating, cGMP analysis, process validation plus experience with FDA endorsed Integrated Management and Balanced Scorecard metrics reporting.
Building high performing, cross-functional teams with strengths in multi-cultural interpersonal communications in European and Latin American markets.
Assessments of new products and product changes regarding formulas, processes and cGMP requirements
Pharmaceutical manufacturing, pharmaceutical packaging
Pharmaceutical industrial engineering, process flow design, facility planning & startup, Scorecard metrics
Experience
2003 – Present Independent Consultant
1989 - 2003 WYETH PHARMACEUTICALS, Collegeville, PA
Associate Director QA Planning
Recruited by 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 QA Administration
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.
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
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
Developed manufacturing and packaging systems for new and existing facilities.
Started up 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.
1981 - 1989 SCHERING-PLOUGH, Kenilworth, NJ
Industrial Engineer
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 major saving each year through cross-fertilization of new ideas between sites.
1969 - 1981 STERLING DRUG
Project Manager
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
Managed the on-site shutdown of the 300-person Milk of Magnesia facility in Glenbrook, CT
Development Engineer
Developed packaging and manufacturing sources of new product entries in trial, regional and national markets, interfacing closely with Marketing.
1962 – 1969 General Foods, Maxwell House Division, Hoboken, NJ
Member of a three-person team responsible for putting on stream a $5M automated green coffee handling and storage system.
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 and BSIE, Fairleigh Dickinson University, Teaneck, NJ