Keith Meyer Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

Greater San Diego Area

Various

San Diego, Ca

Served as Program Manager and Operations Consultant at client sites focused on the development and manufacturing of pharmaceuticals, medical devices, and clinical diagnostics systems. Managed detailed project plans for highly cross-functional strategic projects. Identified project objectives, developed resourcing plans, determined work breakdown structures, and managed key milestones. Incorporated dashboards and project metrics to effectively communicate project status to executive leadership. Embedded quality by design principles into product development and design controls procedures to enable streamlined commercialization of new products. Mapped processes for design transfer to manufacturing teams. Facilitated Kaizen events to drive rapid improvement in areas of inventory management and generation of compliant regulated documents. Benchmarked industry best practices to provide detailed recommendations to clients. Conducted business process mapping, gap analysis, and enhancement through eliciting user requirements, defining statements of work, developing test plans, and executing enterprise system implementations for growing organizations. Leveraged project management tools such as MS Project, Asana, SmartSheet, and Confluence.  Built bridges between client resourcing requirements and internal consulting capabilities. Proactively aligned available consultant resources with key upcoming client projects. Represented firm in trade shows, industry conferences, and business development activities.

San Diego, Ca

Guided Pharmaceutical Contract Development and Manufacturing Organization (CDMO) in best practices for Project Management, Business Development, Customer Relationship Management and Quality Management Systems. Revamped client intake procedures to drastically decrease Time-to-Quotation, significantly increasing customer satisfaction levels. Conducted extensive benchmarking and utilized knowledge of best practices from multiple industries to streamline business processes and develop Strategic Growth Plan for facility. Increased profitability from newly acquired customers through improved alignment with core competencies. Directly managed high-profile client projects, from requirements elicitation and process development to delivery of conforming product. Managed customer retention through development of relevant follow-on offerings. Managed tactical project schedules for pre-clinical and clinical development activities, including but not limited to: Analytical Chemistry, Toxicology, DMPK, AET, MLT, Container/Closure Qualification, and Stability testing.

San Diego, Ca

Served as organizational change agent by identifying and delivering significant business results, focused on improving business processes to increase reliability, eliminate waste and decrease costs.  Utilized Six Sigma project management skills to drive high-impact projects through Quality and Operations business units. Spearheaded “Cost of Poor Process and Product Quality” (C3PQ) strategic initiative to identify and resolve process and supply chain inefficiencies, resulting in $3 million in savings identified.  Eliminated critical product release bottleneck by enabling robust testing methods. Conducted Gage R&R analysis to demonstrate measurement capability of test method equivalency protocol. Used ANOVA to prove statistical equivalency, and authored detailed summary reports for rollouts to international lab sites. Conducted Root Cause Analysis on drug potency variation issue involving product reference standard. Resulted in extensive Design of Experiments to analyze variation caused by techniques of test method preparation. Project was successful in avoiding supply chain disruption, generating 20% improvement in potency loss accuracy and 83% improvement in variability,  Directed international OpEx projects as Six Sigma Black Belt at supplier sites. Initiated and facilitated team-oriented projects to conduct root cause analysis and foster continuous improvement.  Supported a critical manufacturing and test method technology transfer involving stakeholders from the US and Europe. Provided input towards IOQ/PQ/PV report generation and submission to FDA. Conducted statistical analysis and engaged in root cause analysis for Drug Development teams. Utilized Design of Experiments and ANOVA to determine best methods for drug substance and drug product QC testing processes.

Albuquerque, Nm

Optimized supply chain value stream to enable shipment of over 150,000 finished good units per year to B2B and B2C customers. Provided direct management of four employees, and majority management of 14 employees over a three shift, 24/5 operation. Responsible for semi-finished and finished good production planning for entire New Mexico plant, successfully delivering over 200,000 semi-finished devices and printed circuit boards per month. Optimized Business Intelligence reports to promote advanced planning methods and workflow automation within ERP system. Program-managed new product introductions and product lifecycle management configurations. Owned timeline for implementation of new manufacturing and QC processes, including master data configuration in enterprise systems.  Successfully converted all semi-finished testing activities from Push system to Pull system, through Kanban replenishment and visual management. Resulted in 23% reduction in order handling resources required. Served as Site Lead for design and implementation of Oracle EnterpriseOne ERP and APS software for North American distribution. Executed test plans for ERP system integration, managed Go Live and provided continuous improvement and troubleshooting support. Project resulted in consolidation of order line items by over 40%.  Coordinated daily warehouse logistics activities to customers on five continents. Worked with FedEx and Hellmann carriers to streamline transportation processes. Consistently achieved between 90%-95% On-Time Delivery to Request. Regularly had months with zero Customer Complaints while shipping over 15,000 finished sets per month. Delivered North American report-outs in monthly global Sales and Operations Planning meeting. Developed metrics package and facilitated S&OP meeting preparation and execution. Highlighted monthly achievements and potential risks for North American supply chain.

Albuquerque, Nm

 Developed elegant Business Intelligence solutions to effectively collect and analyze data, primarily through the use of Business Objects, MicroStrategy and SQL. Generated reports to measure performance, drive Lean initiatives, control material movement, and enable error-proofing. Represented Planning and Warehouse departments for new product rollouts. Designed and controlled modules for Sales Forecasting, MRP, Work Order Management, Logistics, and Global Branch Integration in ERP system. Aided in setup of Financial Accounting and Controlling modules.  Successfully converted primary customers from manual ordering system to VMI Replenishment with EDI through Oracle Production and Distribution Planning (PDP) software, drastically improving efficiency of planning process and reducing risk of stock-outs.  Served as Site Lead in Guardus Computer Assisted Quality (CAQ) system implementation. Managed Incoming Inspection, In-Process Testing, Customer Returns and Customer Complaint Resolution / Root Cause Analysis.

Albuquerque, Nm

Dexter, Mi