Chickasaw Trl PMB 108
I conceive, design, and implement award winning systems to support Manufacturing, Quality, Procurement & Supply Chain, and R&D business processes. I have directed projects from the technical and business process roles as well as from a joint business & IT role. Over one three year period, the systems I implemented contributed to a 22% ($1.8bn) reduction in costs for indirect goods and services. In typical projects, I apply Lean Six Sigma principles and match an appropriate IT architecture (ITIL) to create a new business process supported by KPIs and SLAs where appropriate. I have been the project leader for an enterprise-wide ERP project, building the system as the Bills of Materials were prepared for the company’s first product launch. I implemented a Global Messaging System for internal, contract, and toll manufacturing that communicated forecasts, orders, and shipments of all company SKUs globally throughout the supply chain, eliminating over 99% of stock outs, producing $15m pa in net income. I am a Certified Information Systems Auditor and have integrated the business and regulatory requirements of each of these systems. I have 3 years’ experience as an internal IT auditor, and seven years’ experience developing cGMP and cGLP systems for Pharmaceutical quality laboratories, R&D, pilot plant, and manufacturing. I hold an MBA from McGill in International Business and a MS in Biochemical Engineering from MIT.
Ab Initio, Lexington, MA (2011-present)
I operate as a data scientist, business & data analyst, and project manager ensuring that users of Ab Initio software succeed. I have done major projects with Heath Insurers, Pharmacy Benefits Managers, Retailers, and Telecommunications companies.
MannKind Corporation, Danbury, CT (2008-2011)
Director, Technical Operations Systems & ERP
As the Director for IT in Technical Operations (Manufacturing, Quality, Supply Chain, Device Development, Facilities) for MannKind Corporation, I implemented systems to support the commercialization of Afrezza®, a novel inhaled, rapid acting insulin. I was responsible for the strategy and architecture of more than half the IT systems in the company.
GlaxoSmithKline, Philadelphia, PA (2001-2008)
Director, Global Procurement IT
is a global pharmaceutical company, with 107,000 employees in over 90 countries
and $40b in sales. Headquartered in
Director, Global Messaging System.
Designed and built a message-based integration for SB’s global supply chain, covering over 200 marketing units, 88 owned factories and over 60 toll and contract manufacturers. Provided cGMP validation for the system and its infrastructure. Established and maintained ITIL procedures for the service, including a registry of standard message types.
Assistant Director, Global Internal Audit
Led Audits of compliance for Shared Services Governance (IT, Finance, HR, Procurement). Liased with Regional management to assess risks and schedule audits. Consulted on Risk Management issues, including data protection and privacy. Presented audit reports to senior management, and provided remediation. Wrote company standards where needed on controls. Represented the company to outside standards boards on audit and control issues.
& French Laboratories, Upper
Assistant Director, Laboratory Automation
and delivered systems to support R&D. Managed 10 staff, half in US, half in
Manager, Pathology/Toxicology IT
Wyeth-Ayerst at this time was part of the American Home Products conglomerate, with business units covering not only prescription and OTC pharmaceuticals, but Brach’s candies, Jiffy Pop, and Ecco houseware. Path/Tox was a shared facility, where I was the senior IT person on site, focused on providing safety data to regulatory agencies for new pharmaceutical and OTC products.
Biogen, N.V., Cambridge, MA 1983-1985
Biogen was at this time a small start up biopharmaceutical company with less than 100 employees. The company was heavily focused on a few research and development efforts, licensing most of its compounds, but developing a clinical trials capability and production capacity.
<![if !supportLists]>§ <![endif]>MBA with concentrations in both International Business & Information Technology
<![if !supportLists]>§ <![endif]>Completed 3 degrees in 4 ½ years: MS Biochemical Engineering, BS Chemical Engineering, BS Biology. MS Thesis: Studies on Immobilized Heparinase and the Heparinase-Heparin Reaction
<![if !supportLists]>§ <![endif]>Top honors academically and for teaching & charitable activities.
Villanova University Radnor, PA
<![if !supportLists]>§ <![endif]>Master Black Belt in Lean Six Sigma. First class to graduate with Heathcare Focus
Certified Information Systems Auditor, CISA #070405. NYC Chapter ISACA active member.
Wharton (U Penn) Business Plan Competition, Judge, 2008-present.
of SAP Advisory Board for Sourcing Relationship Management module. Board
Member of MIT Alumni Association of Delaware Valley. Volunteer with the Parents Advisory Network
of the Bryn Mawr Neonatal Intensive Care Unit, helping parents of very little
patients. Active with Pyramid Club of Philadelphia to promote business
training and opportunities for underserved areas of
Publications & Patents
Gerald L. Fitzgerald, “Implementing and Deploying a Groupware Environment Throughout Pharmaceutical R&D,” PharmAnalysis Conference, Atlantic City, NJ, June 1995.
Gerald L. Fitzgerald, "Future of Automated Chromatography Systems," Perkin Elmer Laboratory Systems Symposium, Tokyo, Japan, 1993.
Gerald L. Fitzgerald, "The Role of Metrics in Computer Systems Validation," 1992 Pharmaceutical Manufacturers' Association Analytical Subcommittee Meeting, Denver, CO.
Gerald L. Fitzgerald and James D. Swanson, "Measuring the Effects of Laboratory Automation: the value of empirical models," J. Auto Chem, 14 (1992) 55-57.
Gerald L. Fitzgerald, William J. Cassano, Karl K. Soneson, Frank L. Tobin, and Preston Hensley, "Development of a Data Acquisition and Analysis System for Measuring Protein Binding Constants Through Ultracentrifugation," 1990 Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy.
Gerald L. Fitzgerald and James D. Swanson, "Measuring the Effects of Laboratory Automation," 1991 Federation of Analytical Chemistry and Spectroscopy Societies, Anaheim, CA.
Robert J. Linhardt, Gerald L. Fitzgerald, Charles L. Cooney, and Robert Langer, "Mode of Action of Heparin Lyase on Heparin," Biochemica et Biophysica Acta, 702, (1982) 197-203.
Arthur C. Grant, Robert J. Linhardt, Gerald L. Fitzgerald, Janice J. Park, and Robert Langer, "Metachromatic Activity of Heparin and Heparin Fragments," Analytical Biochemistry, 132, (1984) 25-32.
Robert J. Linhardt, Zohar M. Merchant, Kevin G. Rice, Yeong S. Kim, Gerald L. Fitzgerald, Arthur C. Grant, and Robert Langer, "Evidence of Random Structural Features in the Heparin Polymer," Biochemistry, 24, (1985) 7805-7810.
US Patent #4,396,762 Heparinase Derived Anticoagulants
US Patent #4,341,869 Process for Producing Heparinase
US Patent #4,373,023 Process and Composition for Neutralizing Heparin
on Laboratory Automation at
Quoted as expert on MQSeries messaging:
Computerworld Article on
User Friendly MQSeries 15 May 2000