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.
Professional
Experience
Ab Initio,
Lexington, MA (2011-present)
Field Engineer
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.
Selected
Accomplishments:
- Developed and
standardized business and IT processes for procurement, receiving,
accounts payable, item and bill of material management, costing, and
forecasting.
- Led the
implementation of ERP
(MS Dynamics GP as an interim to SAP) for the company, covering not only
the new commercial processes, but also R&D and clinical processes
- Validated ERP for cGMP and
Sarbanes-Oxley compliance
- Implemented a standard,
validated workflow engine for incident and change management &
investigations of deviations
- Standardized laboratory
data collection and metadata search for quality and development
laboratories, and implemented a single backup, archive and business
continuity solution across the research, development, and manufacturing
areas
GlaxoSmithKline, Philadelphia, PA (2001-2008)
Director,
Global Procurement IT
GlaxoSmithKline
is a global pharmaceutical company, with 107,000 employees in over 90 countries
and $40b in sales. Headquartered in London,
it is a leader in the important area of vaccines and is developing new
treatments for cancer. Led a global team of 17 (reduced from 42 at the time of
the merger by outsourcing). Defined strategy, architecture, and planning for
Procurement systems. Negotiated with vendors, outsourcers, and offshore service
providers. Managed risks associated with procurement systems, including FDA
& EMEA regulatory and Sarbox audits.
- Built
SpendTrak, using Six Sigma statistical techniques first identifying and
selecting the best spending targets for changes that improved negotiations
with vendors, producing a net reduction in cost of 22% over 3 years for
non-inventory goods and services.
- Defined single
eProcurement process across all GSK business units, and multiple ERP
systems and standardized and outsourced vendor catalogs, resulting in
savings of $25m pa from preferred vendor switches, $28m pa in processing
and headcount reductions and increased quality.
- Defined
process
and set up IT support for an outsourced reverse auction
pilot with a projected savings of $270K from the first 3 auctions.
Later switched outsourcing arrangements, resulting in annual cost
reduction from $3m to $0.3m and increased the number of auctions from 100
to 1000 pa.
- Adapted
standard eProcurement business process to SAP SRM for use in manufacturing
saving $17m pa on $500m in indirect expenses globally.
- Switched
Procurement staff from transactional duties to strategic sourcing,
implementing a Procurement Card for small purchases, and eliminating 100K
paper invoices per year.
- Created system
to set and track standard costs for creative services for advertising and
Public Relations with
first year savings of $2.1m from reductions in
overbilling and second year realized $3m reduction in creative costs from
analysis of standardized costs.
- Integrated diversity
spending measures and targets into eProcurement system, automating the
identification of items and commodities where
diversity vendors had the best deals relative to other preferred
suppliers, increasing diversity vendor usage by 20%, without impacting
overall costs.
SmithKline Beecham, London,
UK 1998-2001
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.
- Turned around a
failed EDI solution, leading the implementation of an MQ Series and XML
based Global Messaging Services for Enterprise
(GMSe), delivering the new messaging system on time and on budget,
the system operated at 1/3rd of the EDI system costs using internal
networks and encrypted Internet links.
- Expanded the
GMSe system to external vendors, toll manufacturers and contract
manufacturers, all targeted suppliers and partners online in the first year.
Their accurate forecasts reduced their overall costs, cost reductions were
recovered to SB in later negotiations.
- Adopted
Check-IT, which was, during the implementation, re-branded as ITIL, which
aligned with the CoBIT audit framework. Documentation for the project
earned high commendations during cGMP audits. Overall productivity was
higher, as was job satisfaction, as staff were able to flex their job
roles by following the documented procedures.
- Established use
of external standards, reducing the cost of developing messaging
interfaces, and received buy-in from partners to develop their interfaces
when the target was an open, published standard and not proprietary.
SmithKline
Beecham, Philadelphia, PA 1995-1998
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.
- Adapted shared services guidelines developed
for European countries to Latin America,
eliminated duplication of 3-5 operating units into a single shared service
per market. All shared services operations met their financial and
operational goals at 6 months, and established two regional data centers,
significantly reducing operating costs.
- Created awareness of control principles and
best practices, allowing Shared Service operations to determine their own
control gaps, making them better prepared for audits, and better focusing
audits on areas of concern.
- Designed and implemented the system and data
control processes for an OTC AIDS test (ORASURE). Product launched on
schedule. No data loss or IT issues during the launch.
SmithKline
& French Laboratories, Upper Merion,
PA 1988-1995
Assistant
Director, Laboratory Automation
Defined
and delivered systems to support R&D. Managed 10 staff, half in US, half in
UK.
Developed standards for lab applications. Managed budgets for system
maintenance and support as well as project budgets. Prepared cost/benefit cases
for new lab systems and assessed impact on existing infrastructure.
- Designed and built a
flexible system for connecting laboratory instruments with a serial
connection, reducing the cycle time to bring new instruments online from 4
weeks to 3 days and eliminating backlog of requests in 6 months.
- Developed business case,
agreed requirements, and delivered a standard chromatography data system
which drastically reduced support and integration costs.
- Created a global R&D
policy for Computer Systems Validation, reducing the costs of compliance
and lowering a major barrier for new system development.
- Redesigned the
instrumentation on analytical ultracentrifuges, re-tasking them to measure
protein binding constants, reducing the screening time for new HIV
protease inhibitors from 6 weeks to 48 hours.
- Consolidated the department
computing resources to a central service, standardized service level
agreements, and used the cost savings to fund expanded laboratory system
support hours.
- Project director for
deployment of 200 Lotus Notes servers and over 4000 clients. Created
standard “Team Connect” workflow applications for common R&D team
activities. The standard team structures easy for people to transition
among several teams, and for teams to share information and deliverables.
- Sponsored several Six Sigma
green belt process improvement activities, including standardizing data
archival, creating a library of common parsing utilities, and areas for
scientists to share their statistical and data analysis routines.
Wyeth-Ayerst
Laboratories, Chazy, NY 1985-1988
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.
- Brought the first VAX into
Wyeth-Ayerst, tripling the productivity of the programming staff.
- Completed 3 FDA computer
and facility inspections without a comment.
- Interfaced laboratory
equipment directly to the computer, increasing lab throughput by 20% and
eliminating transcription errors.
Biogen,
N.V., Cambridge, MA 1983-1985
Systems
Manager
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.
- Automated pilot plant,
allowing investigators to easily set control strategies on any combination
of over 20 variables, enabling optimal production processes to be found
faster and reducing variation so that fewer expensive runs were needed
- Supported researchers in
their use of genetic and protein sequence search software, including
instructions, software modifications, and database maintenance,
contributing to the company’s IP portfolio.
- Prepared the company’s
first online clinical case report forms, allowing clinical data to be
collected every night from every site, enabling close monitoring of
beta-interferon clinical trials and improving communication with clinical
investigators.
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Education
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McGill
University Montreal,
Quebec
§
MBA with concentrations in both International
Business & Information Technology
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MIT Cambridge,
MA
§ 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
§ Top
honors academically and for teaching & charitable activities.
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Villanova
University Radnor, PA
§
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.
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Interests
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Member
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 Philadelphia.
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Publications & Patents
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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
Lecturer
on Laboratory Automation at Medical College of Pennsylvania,
1990
Quoted
as expert on MQSeries messaging:
Computerworld Article on
Wireless MQSeries
26 June 2000
User Friendly MQSeries 15 May 2000
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