Assisted the Drug Discovery unit of a major international pharmaceutical company with the implementation of High Throughput Screening procedures. Evaluated and designed processes to implement and sustain the HTS program. Defined strategy to significantly increase the capacity in a future HTS phase. Identified system requirements needed for implementation.
	Designed clinical trial and supplies management processes and defined system requirements for a MRP II package to manage clinical supplies in a pharmaceutical R&D environment. Project continued into design and implementation phases.
	Led validation efforts of clinical supplies management system including documenting validation master plan, functional requirements, and user test scripts.
	Reviewed a raw material management, formulation, and analytical QC release application being developed for the R&D division of a major OTC consumer products company. Recommended steps to complete the project on schedule, to better meet user requirements, and to properly validate the system.
	Reviewed the QA/QC and analytical research operations at multiple sites of an international pharmaceutical company to identify compliance issues and opportunities for improved operations and cost savings.
	Evaluated the processes for defining the Case Report Forms, filling out of CRFs by investigators, the verification and cleaning of CRFs by Clinical Research Associates and Monitors, and the transport of completed CRFs to affiliate sites and research headquarters for an international pharmaceutical company. Also evaluated a fax-based technology to automate the transport of CRFs and to provide CRF images for CANDA.
	Reengineered the new product development cycle for an international pharmaceutical company by streamlining processes between discovery and application to regulatory authorities.
	Defined the user requirements, implemented and assisted in the validation of a LIMS to support QC and QA activities, including excipients, final products, and packaging components for a generic pharmaceutical manufacturer. Project was completed in six months.
	Performed a technical and organization review, defined the "mission" for the quality department, and established a new organizational structure to fulfill the mission for the European QC laboratories of a major international pharmaceutical company. Reengineered key business processes within the laboratories and between QC and its customers.
	Defined an overall systems and automation strategic plan and systems architecture for the QC department of a major European pharmaceutical company.
	Determined the user requirements, architecture and system integration needs for LIMS and chromatography data acquisition systems to meet the needs of R&D and QC laboratories of a major international pharmaceutical company. Prepared an implementation plan identifying organizational, validation, security, recovery and training needs.
	Developed the strategic systems plan for R&D computing, LIMS, document management, and CANDA of a major international pharmaceutical company,
	Performed an organizational review and restructuring / downsizing to successfully improve performance and profitability of a major international chemical company. Assisted with the implementation of key projects.
	Performed a workflow analysis of the drug metabolism laboratories at domestic and European sites of an international pharmaceutical company. Determining user requirements for LIMS and selected a LIMS to automate the improved processes.
	Defined the strategy for replacement chromatography data acquisition systems of an international pharmaceutical company.
	Developed a strategic systems plan addressing needs in all areas of a pharmaceutical company, including financial, marketing, logistics, manufacturing and R&D requirements.
	Validated a sampling management system for Drug Enforcement Agency regulated samples following FDA guidelines for a large pharmaceutical company.
	Defined a Computer Integrated Manufacturing plan addressing requirements for sales order management, forecasting, production, distribution, QC and R&D for a chemical company.
	Performed a benchmarking study of QA/QC organizations in the pharmaceutical industry looking at organizational structure, controls, and operational issues.
	Implemented a robotics automation program at a major corporate research center.
	Designed Reduced Material, Formulary and Stability Testing software packages for use in the chemical and pharmaceutical industries.
	Performed "Due Diligence" reviews of R&D and Product Development functions of several biotechnology and high technology companies prior to financing initiatives.
	Assisted a major international chemical company with needs assessment and implementation planning to install Laboratory Information Management Systems at plant sites and to integrate them with MRP.