SUMMARY

• Experienced, versatile and innovative technical professional with a background across multiple industries.
• Enjoys challenges and solving technical puzzles to provide optimal answers utilizing new technologies, business process optimization and software quality/testing.
• Very technical and analytical.
• High degree of both organizational and project management skills and enjoys hands - on positions where direct involvement in solutions is required.
• 30 years’ experience leading focused teams and departments; both local and remote; domestic and international.
• Direct experience with regulated environments within FDA, Annex 11, ICH, MHRA and WHO guidelines.
• Experience with GAMP 4 and GAMP5 implementations and remediation. The experience includes working within GCP, GLP, GMP environments and Confidential laboratories.
• Experience with ServiceNow, HP ALM, Trackwise, Remedy and Documentum Confidential for testing, validation and documentation compliance within company QMS Confidential .

TECHNICAL SKILLS

LIMS and CDS Confidential: Waters Empower 2 and 3, Watson LIMS, Galileo; LabVantage, LabWare LIMS and LIMS Basic versions 4-7, PerkinElmer/ABI SQL*LIMS, CyberLab ECMS, LabLynx and several custom in-house Confidential . Certified LabWare LIMS and Empower Confidential Administrator.

Programming Languages: Visual Basic, Java, Perl, Python, C#, FORTRAN, Pascal, Lisp. Programming certifications in Java, Visual Basic and Python.

Project Management Tools: @Task, Liquid Planner, Microsoft Project, Microsoft Project Central, Rational Rose, Requisite Pro, Gantt Plus, Microsoft Excel

Project Management Methods: Agile, Scrum, Rational Unified Process, Waterfall, Project Management Institute. Established PMO Organizations at both Confidential and Confidential .

Statistical Tools: WinNonLin, NonMem, R, SAS, S-Plus.

Artificial Intelligence: over 25 years’ experience with expert Confidential, neural networks, machine learning and genetic algorithms in the areas of financial forecasting, process control, pattern recognition, text mining and data mining.

PROFESSIONAL EXPERIENCE

Confidential, NC

Senior Validation Engineer

Responsibilities:

• Filled several different roles on a project to gather requirements for an automated pressurized metered dose inhaler (pMDI) testing robot.
• The project will be built using the combination of several prototypes existing in Sweden, France and North Carolina.
• The intended target will be a GMP and Annex 11 regulated plant environment in Dunkerque, France. Roles/responsibilities include coordination of requirements gathering between the sites, vendor selection, review of all requirements for compliance (ICH, Annex 11 and FDA) and development of testing and documentation pursuant to corporate standards of Confidential . T he position requires several different skill sets, each used at different times within the process.

Confidential, Fort Lauderdale, FL

Vice President of Compliance and Quality Assurance

Responsibilities:

• Senior management with responsibility for all Compliance and Quality Assurance tasks related to software development and support of a Clinical Trials Management software firm.
• This included Privacy Shield certification, GDPR compliance, review, update and management of all policies and training relating to 21 CFR Part 11, cGCP, GAMP5, Periodic Review, Internal and External audits, software and clinical design testing, disaster recovery and business continuity testing.

Confidential, Miami, FL

Director

Responsibilities:

• Managed and administered several GMP software Confidential, including validation and implementation, under the Quality department at Noven.
• Developed and updated practices on software validation, backup & recovery testing, periodic review, documentation and data integrity. Budgeted and managed upgrades for TrackWise, Empower, LabWare LIMS, MasterControl and internal training program.
• As part of Empower upgrade, obtained Empower 3 System Administrator certification and collaborated with IT to upgrade infrastructure (operating system, database version, Citrix servers).

Confidential, Morgantown, WV

Global LIMS Manager

Responsibilities:

• Manage and oversee all validation efforts for Confidential laboratories across the globe related to LIMS, laboratory automation and database interfaces to scientific and laboratory data.
• Contribute experience and knowledge within committees related to Disaster Recovery, Business Continuity, Data Mining, Business Process Improvement and Knowledge Confidential .
• Conducted vendor audits on the topics of Data Integrity, Disaster Recovery, Computer Confidential Validation and internal Quality Confidential for internal and cloud service vendors.
• Spearheaded reviews and led remediation efforts on application/system inventories, computer validation documentation, SOPs, policies and procedures for new acquisitions in the USA, India and Europe.

Confidential, Morgantown, WV

Senior LIMS Engineer

Responsibilities:

• Senior LIMS Engineer and Project Manager for roll-outs of LabWare LIMS version 6.0 to USA and overseas locations.
• This effort included requirements gathering, all related lifecycle documentation for a GMP and GLP validated Confidential, budgeting, training, support, enhancements, installation and IQ/OQ/PQ testing within a shared Citrix environment.
• Created and updated Audit Survival Kits (ASK) of validation documentation for all automated laboratory Confidential .
• Ancillary projects included development and support of a Global Capacity Planning System for plant production at several sites, and support of Excel and Access tools used as prototype applications within the Quality Control, R&D, Manufacturing and Environmental Monitoring Laboratories.

Confidential, Irvine, California

Senior Project Manager

Responsibilities:

• Project manager for implementation, validation (GMP and ISO) and documentation related to roll-outs of updated serialization support at several manufacturing sites.
• This effort spanned Belgium, Austria and 3 USA-based plant locations to support both the USA and European requirements to provide serial numbers to individual packages sold to consumers of pharmaceuticals and drugs. Also project manager for the documentation remediation of the Automated Plasma Disposition System (APDS) Archival project, which is a custom manufacturing system written in Java and Websphere.

Confidential, Mountain View, California

Technical Project Manager, IT

Responsibilities:

• Project manager for all IT-related aspects of LIMS operations at Confidential ’s Redwood City location.
• This included vendor evaluation, testing, budgeting, validation, implementation, training and support. Also project manager for web site globalization, Electronic Laboratory Notebooks and Digital Pathology projects. Taught lunch hour classes for several staff interested in PMP certification, and part of a committee to establish PMO operations at Confidential .

Confidential, Mountain View, California

IT Project Manager

Responsibilities:

• Project manager for all aspects of setting up new Confidential -regulated laboratory.
• This included evaluation, selection, design, implementation, calibration, validation and certification of LIMS, robotics, barcode Confidential, instrument interfaces and networking.
• Developed SOPs, equipment logs, maintenance schedules, training and validation documents. Secondary projects included interfacing laboratory instruments to LIMS, LIMS Administration and report/automation development.

Confidential, San Francisco, California

Senior Project Manager

Responsibilities:

• Consulting as Senior Project Manager for Development IT group at Confidential, including cross-functional teams and project design and development.
• Main two projects were PKDMAS (PharmacoKinetic Data Management and Analytical System) and support of Confidential research. PKDMAS uses Pharsight’s PKS, WinNonLin, Connectors, AutoPilot and PAF to provide a data warehouse and automated reporting mechanism for PK and PD studies.
• The Confidential work primarily focused on setting up a Linux cluster for statistical and analytical methods against whole-genome data sets for disease-related patterns.

Confidential, Glendale, California

Senior Validation Consultant

Responsibilities:

• Provided project management, validation expertise and team leadership on the Galileo project at Confidential .
• The project involved GLP certification of the Thermo Electron LIMS product named Galileo, for roll-out within Confidential in the PharmacoKinetic/Drug Metabolism (PKDM) research groups.
• Created all documentation on the project and responsible for preparing updates/documentation changes/status reports for committee review meetings on project status.
• Documentation created included Requirements, Project Validation Plan, Design, Resolution Tracking, Requirements Traceability Matrix (RTM), Installation Qualification, Operational Qualification and IQ/OQ/PQ Result reports for Development, Test and Production environments.

Confidentia

Senior Research Scientist

Responsibilities:

• The San Diego office consults to the Confidential in support of medical, surgical and trauma activities throughout the Navy.
• I telecommute to the San Diego, California office, providing research, design and implementation of artificial intelligence and text mining techniques for the Navy’s Tech-Watch project.
• Tech-Watch provides daily news in the areas of nanotechnology, biotechnology and artificial intelligence applications that may prove useful to the Navy.

Confidential

Senior Confidential Analyst

Responsibilities:

• Primary activities were team-building, mentoring and architecture development for existing development team.
• This included weekly meetings with PMO organization of parent company - Genzyme - to facilitate adoption of PMO standards for Confidential projects.
• Assisted the Software Development Manager with technical and infrastructure decisions. Converted several legacy Visual Basic custom modules to C# within a .NET framework.
• The programs were updated to automatically report user errors and program errors to the help-desk database, and provide real-time monitoring of tasks to achieve high throughput testing of human oncology and prenatal specimens.
• Interfaced vendor software and instruments to the custom, in-house LIMS system and automated manual tasks, quality control reporting and error-checking.

Confidential, Glendale, California

Senior Business Analyst

Responsibilities:

• Integrate Enterprise-level management practices for roll-out of Eagle LIMS project to US-based Confidential sites. Role included technical support, GMP validation practices, programming and integration to existing infrastructure. Assisted with implementation and customization of Watson LIMS Confidential using VGL, Visual Basic and PERL.

Confidential, New Jersey, NY

Business Confidential Analyst

Responsibilities:

• System Administrator for Watson v6.4 Laboratory Information Management System (LIMS).
• Completed CFR validation of Watson LIMS version 6.4 (IQ, OQ and PQ) for clinical studies across several research groups for centralized scientific data collection.
• Drafted roll-out implementation for Watson 7.0 for all Confidential sites under cGLP guidelines and practices.
• Provided technical support, training and trouble-shooting for scientific users of the LIMS. Co-developed FAST system using BEA WebLogic to integrate query capabilities from Watson LIMS databases into corporate infrastructure.

Confidential, Chesterfield, Missouri

Scientific Programmer and Project Coordinator

Responsibilities:

• Designed, selected and implemented LIMS Confidential, PerkinElmers, in the Regulatory Science Lab for GMPs for authentication and validation.
• Reports generated for FDA requirements. Interfaced laboratory instrumentation and robotics to a stand alone LIMS
• Designed, selected and implemented LIMS Confidential, LabVantage Sapphire, in Confidential Sequencing Center.
• Designed from scratch 45 full-length finishing sequences for robotic and instrumentation hookup.
• Developed and led projects with Ph.D researchers i.e. Molecular Biologists, Geneticists and Physicists to create scientific genomic data mining and pattern matching applications.
• Designed, selected and implemented an inventory and workflow tracking LIMS for the Roller Bottle Lab, a lab dedicated for growth of cell cultures.
• This customized LIMS was a complete Visual Basic Application.
• Responsible for the support and maintenance of over 24 unique assays, developed in Microsoft Excel and Visual Basic.
• Involved in the redesign and implementation of the successor to the assays, which was developed in Visual Basic by a team of developers and enforces standardization and rapid turn-around for new assays.
• Impact and savings to company; eliminated two consultant positions within the group and centralized data storage, user support and program maintenance.
• Migrated bioinformatics and Confidential software and data from the Agricultural to the Pharmaceutical divisions (Java and Perl on Sun UNIX). Also served as liaison to the Pharma Laboratory Automation Team, developing wireless (802.11b) barcode applications on the Palm Pilot platform (using AppForge and Metrowerks C) for LIMS and freezer inventory applications.

Confidential, St. Louis, Missouri

Bioinformatics Team Lead, Project Manager

Responsibilities:

• Team Lead responsible for Laboratory Automation and Gene Expression projects, using a staff of seven direct-report programmers.
• Supported the Confidential Sequencing Center, an internal high-throughput sequencing laboratory, by special programming projects with robotics, bar code Confidential, database mining and intelligent agents to monitor process flow.
• Championed project management within the Confidential department and successfully changed the culture from “code until it works” to best practices using Rational UML and the Objectory process.
• Coordinated projects with other teams within LSI and with ex-US sites, providing a “SWAT” team of programmers with a reputation for getting the job done.
• Developed a CORBA-based set of components for distributed computing using task scheduling and process monitoring, using Java.

Confidential, St. Louis, Missouri

Senior Consultant, Project Manager, Site Manager

Responsibilities:

• Assigned to Confidential Bioinformatics group as a Laboratory Information Management System (LIMS) implementer.
• Served as Site Manager for Confidential, providing guidance and supervisory resources to other Confidential consultants at the Confidential client site.
• Offered full-time position as a Team Lead with Confidential after four months, with leadership and project management skills cited as foremost reason for the offer.
• Assigned to Southwestern Bell Corporation as a consultant on several projects.
• Project Manager for the company-wide implementation of Oracle Financials and SAP Human Resource modules.
• Created and maintained several web sites for reference and coordination between various teams on the projects, using Cold Fusion web database tool, Visual Basic, HTML and Java.
• Created a web site for the help desk support staff on the Oracle Financials project, which used ODBC connections on the company’s intranet to provide information to technical staff from the company online phone directory (Oracle database) and the SMS Hardware Database (Microsoft SQL Server).

Confidential, St. Louis, Missouri

Software Engineer, Project Manager

Responsibilities:

• Assigned to Deutsche Financial Services as a consultant on several projects. Project Manager -Technical Lead for a large mainframe-to-client/server project (Automated Business Lending, or ABLE).
• The target environment consisted of several RS-6000 Unix servers, with both Novell 4.0 and Win NT 4.0 clients.
• The development tools selected were Forte, Paradigm Plus, C++ and Visual Basic.
• Project manager - technical lead for a medium-sized ancillary project to provide report viewing and delivery services from any internal platform (mainframe, UNIX, Novell and NT) to the client desktop.
• Served as technical lead for a “strike force” team, which addressed pressing business issues covering project development, internal standards and methodologies, and actual programming for business-critical projects, using Visual Basic, Visual C++ and Visual Source Safe.
• Worked for six months at Union Pacific Railroad as a Visual Basic and Visual C++ developer on two projects.
• One project (named “Assistant”) used Visual Basic and C++ to create a user-friendly front-end interface to the different mainframe computer Confidential used at both Union Pacific and Southern Pacific Railroads, allowing technical staff to track railcars, solve routing problems and provide customer information on the two different Confidential with a consistent interface.
• The other project provided a dial-in telephony system for customer assistance, which queried the mainframe database to provide verbal car locations and estimated arrival times for intermediate waypoints over the phone, based on a customer’s responses to the menus on a touch-tone phone.

Confidential,Tulsa, Oklahoma

Senior Analyst, Project Manager

Responsibilities:

• Project Manager and Coordinator for all internal projects. Windows, Client/Server and Novell 3.12 development platforms.
• Initiated, selected products, designed and developed CD Mastering project, providing Visual Basic selection menus to provide engineering CAD drawings to field personnel on portable computers with portable CD-ROM. Several large client/server applications using Visual Basic, Borland C, Visual C++ and several third-party software packages.
• Led project that provided Client Invoicing in multiple languages directly from GE process control data collected at the site.
• This project required an extensive engineering background, remote communications through Wide Area Networks (modems, fax, radio and pager communications supported), Novell Netware 3.12 program development, and real-time graphics at the client sites.
• Responsible for internal competitive information newsletter for both Computer and Cogeneration Industry news stories.
• Responsible for review and recommendations on new technology and applications.

Confidential,Tulsa, Oklahoma

Consultant, Project Manager, Site Leader

Responsibilities:

• Consultant specializing in client/server development environments. Responsible for marketing support, technical support, technical presentations, management of seminars and workshops, management of project teams, application development, and proposal preparation.
• PowerBuilder, Visual Basic, Visual C++, Object Oriented Analysis and Design, Oracle SQL, Windows API, Client/Server Development in multiple languages, Project Management.
• Presented papers and a multimedia presentation to the Oklahoma Artificial Intelligence Symposium at both 1992 and 1993 conferences.
• The title of the presentation was “Neural Networks Applications For Investing”, and used Icon Author software as the multimedia presentation system.
• The multimedia demo started with jazz music, and at the opening time the computer introduced itself and the seminar, then introduced the developer for live demonstrations using companies, which the audience selected. The presentations were geared towards business applications of artificial intelligence, namely using neural networks for forecasting of non-linear dynamic patterns.

Confidential, Tulsa, Oklahoma

Senior Business Confidential Analyst, Project Manager

Responsibilities:

• Responsible for support, maintenance and enhancement of Natural Gas & Liquids Supply and Distribution software.
• Platform consisted of Novell network, Sybase SQL Server, OS/2, and Application Manager (AM - a fourth generation application development language).