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
Led validation efforts of clinical supplies management
system including documenting validation master plan, functional requirements, and user
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
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
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
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
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.