Project manager for an electronic laboratory notebook system (ELN) for a pharmaceutical. Project spans R&D and Quality and includes the following: business process analysis and harmonization, user requirements definition, request for proposal and vendor demonstration requirements and facilitation. Key to the role is to assist in the strategic direction for system design, development and deployment.____________________________________Sub-contracted through CSOLS, Inc. to lead documentation efforts for a global implementation which includes Empower, STARLiMS, NuGenesis and Business Objects. System scope covers standard LIMS functionality with the addition of electronic laboratory notebook use and QA product disposition. Manage a team of 6 individuals and am a Project Manager within the Program. Documentation team scope includes but is not limited to software development lifecycle, validation, operating procedures and change controls both from a corporate and a site perspective. Additional documentation responsibilities include the assessment and modification of existing effective documentation impacted by the implementation. In addition to the above was responsible for: -business continuity planning and documentation for the program as well as for creating presentations to communicate the system architecture plans for disaster recovery and business continuity.-Global change control facilitation and documentation for the system implementation. Required vetting and assessment efforts with Quality, Regulatory, Manufacturing, Validation and IT.-Revising/authoring of system architecture documentation.____________________________Responsible for Standard Operating Procedure development oversight and overhaul of existing documentation for a global LIMS STARLiMS system in a biotech copmany. Responsible for monitored performance qualification protocol development.

SME and eventual Project Manager for Global LIMS cross divisional implementation. Covers Clinical, Quality, Research and Development Divisions. Responsibilities include but not limited to Business Process assessment and mapping, Harmonization within and across divisions, project management, Budget/Schedule oversight, validation and implementation activities. Project Manager for Scientific Data Management Systems (SDMS), Empower and Electronic Laboratory Notebook systems

Hired as Senior Systems Analyst, promoted to Manager then named Global LIMS Program Manager-Established the Corporate Laboratory Information Management Program for Bristol-Myers Squibb Operations Division-Managed budgets of up to $12M-Managed & developed internal staff of six and external staff of 22-Negotiated discounts in software licensing and service costs for vendor contracts, saving from 40-70%-Turned around a chronically failing project, successfully deploying within 14 months as planned

• Lead for business workflow re-engineering projects• Managed development and technical staff for the deployment of large scale LIMS implementation in under 1 year, as planned• Designed database, programs and system reports• Developed and delivered system training programs• Lead for Software development efforts• Wrote SQL reports and VGL programs

• Management Consultant with regards to operational efficiencies and communications• Implemented pre-clinical/clinical testing, samples and data management procedures• Trained clinical trial sites on sample collection and data management procedures

• Conceptualized and developed an Applications group within Bioassay Department• Selected & implemented company wide Laboratory Information Management System (LIMS) and Business Objects • Managed tox, pre-clinical/clinical studies and associated testing to ensure the integrity of the data and the meeting of GCP, GLP and GMP regulations • Worked in the Bioassay laboratories performing method development, routine testing (bulk, raw material,finished product), toxicology, pre-clinical, clinical and stability testing• Key compliance team member responsible for inspection readiness. Cross Divisional effort resulting in standardized/streamlined procedures and systems across Quality laboratory and Assurance groups. Responded to questions during FDA, Canadian, and EMEA inspections for AvonexTM• Key clinical trial process re-engineering team member responsible for the data transfer piece of the process between the laboratories and the data management/biostatistics groups.

Performed routine allergy/immunology testing (RAST, IGE, Mancinis, ELISA's) Prepared polyclonal antibodies for use in transplant patients and performed associated flow cytometry testing to monitor transplant acceptance/rejection. Responsible for managing information as a clinical trial site. Required the management of samples, testing and results for physicians as well as several CRO’s and Pharmaceutical companies. Clinical trial testing site. (utilized Cerner LIS)Routinely performed inspection readiness for JCAHO inspections and participated in issue resolution where required.