William Hellier Email & Phone Number

Sugar Land, Tx, Us

• Business analyst and solution design architect for informatics solutions including LIMS, ELN, CDS, Biorepository and Animal Management.• Data Load Senior Informatics consultant for system configuration and validation for global LIMS solutions.

Business/Systems Analyst and Project Manager specializing in compliance and gap analysis to meet automation and performance improvements needed to maintain competitive advantage in today's biotech-pharmaceutical laboratories in a regulated environment.

Gaithersburg, Maryland, Us

Key accomplishments:* Developed LIMS solution in one month for MedImmune Manufacturing Sciences and Technology group to solve critical business need for laboratory sample management and reporting using Agile Methodologies* Developed and implemented reporting automation using email and scheduled reports to shared repositories, reducing time spent result reporting by 60% for QC management.* Developed and implemented “paperless sample login”, eliminating need for paper forms used for sample submission, saving an estimated two FTE at Frederick facility alone.* Developed and implemented LIMS solution for Environmental Monitoring for all MedImmune operations facilities, improving reporting reliability and saving about one FTE for each site.* Led effort to implement fully validated LIMS solution in less than three months to replace failing Environmental Monitoring Software System at MedImmune PA site.* Developed and implemented replacement of manual APR/AR reporting with validated LIMS report, reducing reporting effort and time frame to one third of original* Worked with QC staff to identify and implement LIMS reports and streamline lab processes, resulting in 3 FTE staff savingsManaged group supporting QC lab systems at the Frederick site, which is the center of excellence for MedImmune manufacturing. Focus was automation and process improvement using LIMS.After position moved to OIS in 2009, supported all enterprise Quality (cGMP) systems used for laboratory operations. Served as IS technical lead for following critical projects: QC LIMS and EM LIMS enhancements; Agilent OpenLAB replacement for Chemstation/ChemStore; MedImmune GO LIMS project - system interfacing (SAP:LIMS) and lab instrumentation (Velquest SmartLab).

Gaithersburg, Maryland, Us

Key accomplishments:* Managed and implemented ChemStore database server replacement and date migration with zero downtime* IT technical lead for all system upgrades and implementation of Stability and Solutions management modules * Worked with Quality Information Systems group to streamline and harmonize report request process for QC LIMS, reducing report implementation time by two thirds* Managed consolidation of QC LIMS (MedImmune Vaccines and MedImmune) to single server cluster* Managed move of QC LIMS servers from Mountain View, CA to Gaithersburg, MD data center with minimal (six hour) downtimeResponsible for providing primary IT support for validated (cGxP) lab systems – administration, troubleshooting, documentation and change control. Systems included QC LIMS, Environmental Monitoring Software System (EMSS), Sample and Data Management System (SDMS), Agilent ChemStore, and other applications. Served as IT technical lead for all enterprise laboratory system projects - Global LIMS; ChemStore CDS Upgrade; Process Control and Development Bioreactor SCADA system; QC LIMS enhancements; Applied BioSystems PCR system, etc. Author or approver for technical work instructions, SOPs, and validation documentation (URS, FRS, DCS, IQ/OQ) for lab systems. Served as primary contact for MedImmune Laboratory Automation initiative.

Gaithersburg, Maryland, Us

Note: Aviron was acquired by MedImmune, Inc., in 2002 Key Accomplishments:* Served as IT lead for highly successful LabManager LIMS project implementation – implemented and validated for five sites in US and UK in seven months.* Developed and implemented interface from LIMS to SAP for analytical results saving one FTE for manual entry.* Developed and implemented over 40 Crystal Reports, including validated reports for CofA, Annual Product Review, and lot release.* Developed interface for CELISA instrumentation to automate transfer of data to instrument data system from LIMS and result data back into LIMS.Served as IT lead and LIMS expert to implement first LIMS for Aviron. Identified and selected computer validation resources. Played key role in developing validation model for IT, including authoring, reviewing and approving validation documentation. Identified LIMS vendors and coordinated selection process. Responsible for technical LIMS administration and troubleshooting, documentation and change control.

Somerset, Nj, Us

Key Accomplishments:* Managed more than thirty Lab automation solution projects to successful completion, ranging from small custom application modules to multi-site, enterprise wide solutions for environmental testing, forensics, and clinical testing sectors.* Saved at risk customer relationships by taking over stalled projects and moving to completion.* Developed methodology improving migration of legacy LabVANTAGE applications to current software, resulting in cost effective solutions with better customer satisfaction.* Created process and tools to reduce customer level of effort for initial reference data loading for implementation by 50%.Managed all aspects of LabVANTAGE client/server LIMS solution projects. Gathered and analyzed customer workflow and requirements information, including interfaces for instruments and other systems. Created implementation project plan, technical specifications, and ROI analysis, drawing on experience and professional laboratory background. Developed customer and project specific training materials, performing all project related training on-site. Developed custom LIMS applications, interfaces, and reports as needed, using PL/SQL, Oracle Developer 2000, and proprietary ACS 4GL language.

Oakland, Ca, Us

Key Accomplishments:* Managed $500K LIMS project within budget and ahead of schedule, resulting in three fold improvement in operational efficiency, through report automation, instrument interfacing, workflow optimization, and company wide access to laboratory data.* Led effort to form LIMS user group and chaired first two years* Developed work/project implementation and tracking system, which improved response to client requests 200%.* Identified and implemented technology for automation, yielding tenfold productivity increase and reducing staffing needs by 30%* Initiated and led laboratory reorganization, with focus on laboratory and client support.* Deployed first PC LAN in company, allowing consolidation of data storage and application sharing.Managed chromatography and client services groups for full service environmental and industrial hygiene testing laboratory. Managed all laboratory computer resources and automation. Served as project manager for LIMS, developing RFP, URS and FRS and implementation plan. After implementation, administered 400 user LIMS, including Oracle database on UNIX server and trained replacement administrators. Developed and implemented custom reports and application modules for LIMS.

Bachelor Of Science (B.S.), Biochemistry And Mathematics

Bachelor Of Science (Bs), Biochemistry