Geraldine Jay Hall, M.B.A., Cscp Email & Phone Number

Gaithersburg, Maryland, Us

Manage 3 direct reports as country / regional External Manufacuring Lead overseeing Contract Manufacturing Organizations (CMOs) producing COVID-19 vaccine including planning, coordination, and control of all manufacturing and operational logistics within $36M budget and contractual standards. Monitor supply partner on-time quality and compliance with global regulatory standards. Identify, evaluate, and propose manufacturing organizations and strategies. Serve as primary contact from inception to implementation of GMP manufacturing at CMOs. Direct external contract development and manufacturing organizations from process transfer through commercial supply. Champion continuous improvement opportunities and resolution of production issues. Assist in preparation and technical review of regulatory CMC documents. Support Global Regulatory Operations (GRO) coordinating all aspects of submission activities to support continued development and approval of Novavax’s investigational vaccines through licensure. Collaborate with Clinical Project Management (CPM) team monitoring operational delivery of clinical studies including inspection readiness and risk management.Selected Skills:* Leadership & Team Building* Country / Regional External Manufacturing Operations Management* COVID-19 Vaccine Planning & Manufacturing* Budgeting & Logistics Optimization* Supplier Partnership Management* Quality Assurance & Compliance* Contract Development & Management* Continuous Process Improvement* Production Issue Resolution & Innovation* Vaccine Approval & Licensure* Risk Assessment & Mitigation* Supply Chain Management & Vendor Relations* Contract Manufacuring Organization Management

Directed 5 team members managing External Manufacturing Operations encompassing Senior Planning Specialists, Senior External Quality Associate, Senior Procurement Specialist, and Senior Engineering Specialist with $25M budget. Managed relationship at contract manufacturing site to meet customer demand ensuring excellence in supply, compliance, cost, and continuous improvement. Oversaw cross-functional external team of Quality, Technology, Supply Chain, and Procurement partners delivering daily, weekly, monthly, and annual requirements. Established contract manufacturing strategy, business objectives, and priorities to gain alignment with partners. Built and fostered strong business relationships. Developed and managed budget for manufacturing and inventory control. Identified and managed risk at contract manufacturing site.Selected Skills:* External Manufacturing Operations Management* Procurement & External Quality Controls* Engineering & Contract Manufacturing* Customer Relationship Building* Continuous Process Improvement* Regulatory Compliance & Cost Reductions* Strategic Partnership Development* Budget Development & Management* Manufacturing & Inventory Control* Risk Assessment & Mitigation* Leadership & Team Building

Led 4 Senior External Manufacturing Supply Chain Specialists managing and integrating functional and tactical planning and execution for >100M doses of sterile drug product and vaccines externally sourced in North America and Europe. Directed team of Supply Chain Managers supporting continuously improving supply chain planning and execution activities. Communicated supply scenarios to senior leadership and other stakeholders. Oversaw supply chain projects including source changes, external partner integration, and product launches. Championed profit and inventory planning initiatives as well as inventory reconciliation efforts. Supported external partners developing robust supply chain processes. Negotiated product volumes / delivery timing and partnered with Procurement team developing spend strategies and negotiating contracts and renewals. Conceptualized and communicated supply scenarios and project supply prioritizations with relevant stakeholders.Selected Skills:* External Manufacturing & Supply Chain Management* Vaccine & Sterile Drug Product External Manufacturing / Distribution* Continuous Process Improvement* Full Lifecycle Project Management* Sourcing Optimization & Streamlining* Product Volume Negotiations* Strategic Partnership Development* Contract Negotiations & Renewals* Performance Improvement* Supply Risk Mitigation* Shipping & Logistics Process Standardization* System Planning & Implementation* Forecasting & Inventory Level Optimization* Staff Development, Coaching, & Mentoring

Coordinated logistical functions including scheduling shipments and establishing shipping lanes. Mitigated supply risks and imbalances to meet patient need and issued forecast to external partner manufacturing sites. Reported customer service metrics, evaluated issue root cause, and implemented corrective actions to improve customer satisfaction.Selected Skills:* External Manufacturing Logistics* Supply Chain Management* Supply Risk Mitigation* Strategic Partnership Development* Performance Measurement / KPIs* Customer Satisfaction & Retention

Developed and distributed site production plans in alignment with established profit plan volumes. Monitored KPIs and mitigated risks to meet global supply. Led annual Center for Disease Control (CD) stockpile inspections resulting in no observations. Reduced lead times 25% by optimizing external manufacturing distribution and logistics. Developed product prioritization strategic plans to achieve targeted inventory levels.Selected Skills:* Distribution Site Production Plan Development* Performance Measurement* Global Supply Risk Assessment & Mitigation* Stockpile Inspections & Lead Time Reductions* External Manufacturing Distribution & Logistics

Planned manufacturing of 50M+ doses of viral vaccines on capacity constrained filling lines to meet global demand. Implemented firm scheduling via use of Kanban system and production planning / scheduling in SAP to prioritize and balance manufacturing priorities increasing manufacturing efficiency.Selected Skills:* Manufacturing Planning & Capacity Constraints* Kanban System Implementation* Production Planning & Scheduling* Manufacturing Productivity Improvement* Supply Chain Planning & Logistics Optimization

Mba, Management

Bachelor Science, Biology