Independent Information Technology consulting, mentoring - especially in FDA GMP environments+ Tactical and strategic IT planning, review, advice, guidance, validation+ IT compliance, budgeting, procedures, startup or stabilization+ Regulatory inspection preparedness+ Major systems readiness/planning seminars for the life sciences industry+ Privacy and Security evaluations and recommendations+ Manufacturing Execution Systems (MES)+ Enterprise Resource Planning (ERP)+ Electronic Document Management Systems (EDMS)+ Personalized medicine manufacturing

Sr. IT Security and Validation Analyst and Auditor

Responsible for IT staff and functions across all locations as the company sustained growth through the recession through both organic growth as well as domestic and European acquisitions.Transformed the information technology department from a siloed group into a cross-functional business partner.Stabilized infrastructure and service delivery, upgrading most key systems while maintaining cost controls.Created platform for selling and supporting existing products and those of acquired businesses by implementing an integrated SAP/CRM service management system. The system was key to our plan to support the rapid growth of the business with the introduction of a new medical diagnostic instrumentation platform and related assays.Supported integration efforts after Gen-Probe was acquired by Hologic.

Independent Information Technology consulting- Tactical and strategic I.T. planning, review, advice, guidance- IT compliance, budgeting, procedures, startup or stabilization- Major systems readiness/planning seminars for the life sciences industry: + Manufacturing Execution Systems (MES) + Enterprise Resource Planning (ERP) + Electronic Document Management Systems (EDMS) + Barcoding + Personalized medicine manufacturing

Led development of a highly motivated, professional, service oriented information technology team for a pioneering firm developing a patient-specific, personalized treatment for non-Hodgkins lymphoma cancer.Led the creation of a strategic information technology plan to support efficient, economical and compliant paperless manufacturing to avoid a 10-fold increase in the staff managing batch release.

Developed cost-effective infrastructure for and managed the development, operation, and customer support of a business-to-business scientific web site, Oracle based tools, and database products and related support systems for a startup company providing cheminformatics and chemistry procurement services supporting drug discovery.

In preparation for becoming a publicly held company, led IT team in a series of projects with very tight time frames to upgrade and stabilize company accounting, manufacturing and distribution (ERP) computer systems leading to increased capacity, Euro compliance, and Year 2000 compliance, and the setup of an additional manufacturing site.

Stabilized company computerized systems, applications (ERP) and support procedures, managed outsourced services, created departmental and corporate IT policies, oversaw Intranet development, supported GMP applications and related FDA validation processes, and developed infrastructure plans for use after FDA approval of the company’s first product, while reducing costs.Worked closely with Finance in the selection and implementation of project cost accounting and budgeting systems, streamlining the budgeting and reporting process.

Coordinated the conversion of business systems of six acquired companies, and of the integration of the business unit’s systems with Baxter Healthcare’s corporate systems in one year.

Founder and senior member of a team responsible for all voice and data systems for organization, from pre-IPO to acquisition by Baxter Healthcare. Implemented off-the-shelf and custom systems for ERP, high availability call-center, and clinical needs for servicing open-heart surgery life support contractors at hundreds of hospitals. Additionally responsible for the call center which dispatched clinical staff to surgeries.

Responsible for software product QA, user installation procedures and manuals, product release control, technical customer support and programming environment in an organization providing strategic IT planning software and services for Fortune 2000 organizations.

Maintained and enhanced a proprietary operating system, with special emphasis on the fault tolerant file subsystem.Developed QA and release control functions for business intelligence products.

Maintained a real-time plant maintenance, monitoring, and control system (SCADA).Programmer for a major rewrite of an automated warehouse control system.