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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.
EXPERIENCE
Agalloco & Associates, Belle Mead, NJ - (12/91 to present) - President - Provides a wide range of technical services to the pharmaceutical and biotechnology industry in the areas of process and product validation, sterilization, aseptic processing, isolation technology, sterility assurance, facility design and computer system validation. Major projects have included: validation master planning, validation of new products, BPC process validation, sterilization-in-place, aseptic processing, facility design, assistance in NDA preparation, regulatory compliance, cleaning validation and sterilization processes. Works closely with other consultants on larger projects. Field execution of validation for isolation technology. Has assisted over 120 firms in the United States, Puerto Rico, Canada, Mexico and Western Europe.
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)
Engineering Project Manager (6/79 to 2/80) - Prepared capital project proposals for dosage form and BPC facilities. Responsible for TSCA and OSHA compliance planning. Facility planning, feasibility analysis, cost estimation, ROI and technical input required on all projects.
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)
Junior Chemical Engineer - Assisted in the scale-up/start-up and troubleshooting for new and existing bulk pharmaceutical chemicals. Served on a BPC facility start-up team in Puerto Rico.
EDUCATION
M.B.A. (Pharmaceutical Studies) FAIRLEIGH DICKINSON UNIVERSITY, Teaneck, NJ, 1983
M.S.Ch.E. POLYTECHNIC INSTITUTE OF NEW YORK, Brooklyn, NY, 1979
B.S.Ch.E. PRATT INSTITUTE, Brooklyn, NY, 1968
MILITARY
1st Lieutenant, United States Army, (11/68 to 11/70) - Transportation Corps, Honorable Discharge -Service in Texas, Oklahoma and the Republic of Vietnam. Honor Graduate, TOBC 5-69.
AFFILIATIONS
Parenteral Drug Association: - Held numerous positions in the association including: President; Second Vice President; Director; Committee Chairman; Committee and Task Force Member; Founder, Metro Chapter - 1980 to present
Validation Discussion Group: Co-founder and Member, 1980-1991
Pharmaceutical Manufacturers Association: Member, Computerized Systems Validation Committee, Program Co-Chairman, Program Committee Member, 1983-1991
ISPE - Member, 1980 to present
American Glovebox Society - Member,1996 to present
PRESENTATIONS
Presentations at numerous Pharm Tech, PDA, PMA, ISPE, DIA, Interphex, IIR and other industry organization meetings. Presented training courses on various aspects of process and systems validation for PDA and other organizations.
PUBLICATIONS
Co-editor, Validation of Aseptic Pharmaceutical Processes, second edition published in December 1998. Author or co-author of multiple chapters on aseptic processing, sterilization validation, validation practice and isolation technology in different texts.
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.