Elijah Mcbride Email and Phone Number

• Lead re-design implementation of all inspection plans (IPs) for 4000+ quality managed materials for Marketed production and Clinical production.• Managed over 500+ inspection plans from creation, revision and implementation for marketed and clinical production as well as raw material testing and testing for intermediates production.• Successfully represent SAP Quality Assurance (QA) as local advisor on the Bayer Global SAP Quality Management council.• Operated as primary point of contact for QA Sap related issues/topics and represented QA as SAP Subject Matter Expert in cross-functional teams..• Successfully supported numerous internal and external audits as well as national and international regulatory inspections.

Business System Analyst I, SAP Production Recipe & Document Development Group Technical Support for Drug Product Commercial and Clinical SAP redesign Project.• Support implementation, document design decisions into governing data rule catalog, develop recipe authoring training as subject matter expert, facilitate recipe authoring training.• Key member and interim lead for Business System Integration Level 2 Team – lead cross-functional team to track, resolve and deploy company-wide trouble tickets. OE Analyst, Manufacturing System Improvement GroupDevelop Class A Business Process Instructions for Integrated Data Verification and train National and international sites.• Supported and delivered SAP on-going training to SSFP – trained well over. • Executed Integrated Data Verification for Genentech Singapore.SAP Implementation, Support Project Member Support ERP transcriptional troubleshooting.• Created document and deliver ERP system and business process training to various levels of the organization.• Provided business process design support to Business Process Managers.• Analyzed process and systems performance and identify improvement opportunities (system fixes and enhancements).• Participated and or led roll-out of future ERP system enhancements.• Assisted in or lead the development of Business Process Metrics and Reports.• Created validation testing before software launch to support production simulation.• Communicated proactively with stakeholders regarding progress, issues and plans for resolution.• Developed and utilized project plans to coordinate participants and track and report progress.• Operated with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals.Additional Genentech ExperienceMFG Supervisor, Drug Substance GroupLead Mfg Technician, Drug Substance/ Final Purification Group

• Support ERP transactional troubleshooting• Create, document and deliver ERP system and business process training to various levels of the organization• Provide business process design support to Business Process Managers• Analyze process and systems performance, and identify improvement opportunities (system fixes and enhancements)• Participate and or lead roll-out of future ERP system enhancements• Make recommendations regarding best options to Business Process Managers based on analyses and system subject matter expertise• Assist in or lead the development of Business Process Metrics and Reports• Support Production SimulationCommunicate proactively with stakeholders regarding progress, issues and plans for resolution• Develop and use project plans to coordinate participants and track and report progress• Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals• Networks with other PROP super-users and continuously improves system skill set

• Support employee development with one on one employee goal tracking and assessment• Tracked and organized shift resources to ensure on time production• Investigate production deviations with internal groups such as QA, QCIP, MSAT, PCs, and Process Scientists• Developed and implemented an on-the-floor metrics program for the functional area and lead its implementation throughout the drug substance organization• Became certified as a trainer through the 5S program and assumed the role of S.P.O.C for the Final Purification Area • Lead a team through development and implementation of a lean Parts Management System in Final Purification and was an integral member of the program rollout for the Drug Substance organization

• Support and coordinate day to day production operations• Manage priorities and shift resources to ensure day to day operation are completed per production schedule• Analyze and escalate production deviation in a timely manner with the appropriate groups• Participate in daily coordination meeting and lead daily shift meetings• Re-vamped and re-authorized the Filtration Technology Team by working closely with the MSAT/ PS – FTT