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James P. Agalloco
Thirty years of management experience in pharmaceutical manufacturing, pharmaceutical engineering, computer systems validation, technical services and research and development. Internationally recognized expert on process and systems validation. Extensive knowledge of pharmaceutical and BPC manufacturing technology. Exhibits a superior ability to communicate.
Bristol-Myers Squibb Technical Operations, New Brunswick, NJ (5/90 to 12/91) - Director, Validation and Technology - Directed Validation, Automation and Technical Documentation activities for BMS New Brunswick. Served as a technical resource for BMS Technical Operations in all aspects of pharmaceutical manufacturing. Active participant in several new product and facility task forces.
Squibb Technical Operations, New Brunswick, NJ (4/88 to 5/90) - Director, Worldwide Validation and Automated Technology - Directed Validation and Automation activities for Squibb facilities in 27 countries around the world. Served as the major technical resource of Squibb Technical Operations in the areas of facility design, facility start-up, sterilization, aseptic processing, validation and automation. Participated actively on major product, process, facility and equipment projects within STO. Directed the validation and automation phases of a $25 MM expansion of Squibb's parenteral facility in New Brunswick. Major support provided to sterile bulk manufacturing facilities.
Pharmaceutical Engineering, Department Manager - (2/80 to 4/88) - Managed the development, execution and documentation of validation efforts for STO worldwide. Served as the principal source of validation expertise within Squibb Corporation. Developed the department into a major resource for process engineering and automation. Successfully led the validation of a $62 MM sterile facility through FDA review. Primary spokesperson for validation to FDA and other regulatory agencies. Responsible for validation of all dosage forms.
Pfizer Pharmaceuticals, New York, NY (9/73 to 2/80)
Senior Production Supervisor (9/75 to 6/79) - Managed production operations for sixty (60) different sterile and oral liquid and powder products. Major areas of responsibility included cost control, cost reduction, GMP compliance, scheduling, equipment selection, and process trouble shooting.
Manufacturing Engineer (4/74 to 8/75) - Formulated, piloted and scaled-up numerous pharmaceutical dosage forms. Coordinated production review of new products from R&D.
Research Engineer (9/73-4/74) - Managed the ongoing development and isolation of an anti-cancer agent from fermentation extract through finished bulk drug. Budget of $250,000 to produce 1 Kg of active material. Managed this same activity [1976 and 1979] part-time while serving full time in other capacities.
Merck & Co., Rahway, NJ (3/71-8/73)
Authored or co-authored over fifty technical papers on: validation, aseptic processing, change control, computer systems validation, sterilization-in-place, cleaning validation, environmental monitoring, and isolation technology.
Co-editor, Handbook on Isolator Technology: Applications in the Healthcare Industry multi-chapter text in development for publication in 2002 by Marcel-Dekker.
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