Gary Marshall Email & Phone Number

Led LIMS and Metrology group, managing the execution of Laboratory Information Management System (LIMS) projects, and equipment qualification, calibration, and preventive maintenance activities.• Managed user support for LIMS and other applications and equipment.• Ensured existing computer systems were configured and implemented to support business processes.• Created and revised Standard Operating Procedures (SOPs) related to all aspects of the LIMS and Metrology function.• Managed Equipment Management and Environmental Monitoring Systems for scheduling and recording all equipment related calibration and maintenance and monitoring all temperature and humidity controlled GxP equipment and rooms.• Implemented a risk-based LIMS configuration change process that reduced documentation required and implementation time by ~70% (from 6 months to 2 months).• Developed a project tracking system and enhancement request process to allow cross-functional prioritization of LIMS changes.• Executed an Equipment Disposition Project to align equipment with business needs and reduced equipment maintenance and validation costs by >$75K.• Provided leadership of office and laboratory move to new building and laboratories, ensuring successful and GxP compliant move of equipment. Collaborated with Facilities, architect, and laboratory management to design new space.

Associate Director, Research Informatics (2004 – 2006)Provided leadership, support, and oversight of the Workflow Systems and Scientific Information Resources groups within the Global Research Informatics organization.• Interfaced with all Palo Alto scientists to define, prioritize, resource, and execute informatics projects.• Provided leadership of the activities of the Workflow Systems group responsible for the validation and implementation of applications used by GLP and GMP departments (Toxicology, Pathology, Pharmaceutics, DMPK, Analytical Chemistry, Process Chemistry).• Provided leadership of the activities of the Scientific Information Resources group, responsible for the physical and electronic libraries, and management of laboratory notebooks and records.• Global project lead for selection, validation, and implementation of a global Bioanalytical LIMS.• Local Information Management (IM) lead for validation and implementation of global Pathology and PK LIMS applications.• Local IM lead on Global LIMS Coordinating Committee that developed and executed global strategy to harmonize and centralize Non-Clinical Development LIMS to reduce overall cost of ownership and enable global information sharing.• Local IM lead on global team that completed a risk-based global harmonization of CSV policies, procedures, and documentation to reduce CSV costs and project timelines.

Provided leadership, support, and oversight of DMPK scientists.• Represented DMPK on Project/Clinical Study Teams for a novel compound undergoing PhI/II clinical trials.• Supervised a group of scientists ensuring that bioanalytical assays were developed and validated and that analyses and reports for clinical, toxicology, metabolism, and pharmacology studies were completed according to GLP.

Provided leadership, support, and oversight of Non-Clinical Development Information Management group.• Ensured that ~20 software applications were validated and supported in accordance with GLP and GMP regulations, including generation, review, or approval of complete validation document sets plus operational documents such as IM SOPs.• Completed the Roche Palo Alto 21CFR11 remediation activities, including generation and execution of application specific remediation plans.

Provided project management, system management, and CSV documentation for validation and user support of LIMS and other software used by Non-Clinical Development.• Generated the documentation required to complete IM projects in a regulated environment including validation plans, IQ/OQ protocols, user acceptance test plans, reports, SOPs, etc. • Completed the validation, implementation, and maintenance of various GxP software applications.

Provided leadership, support and oversight of scientists performing bioanalytical assay method development and validation.