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.
• Implemented a risk-based LIMS configuration change process that reduced documentation required and implementation time by ~70% (from 6 months to 2 months).

• 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.
• 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.

• 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.

• 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.
• 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.