Supply Chain Senior Director

…Continued…

Elizabeth Wentworth-Kelly *************@*****.*** • 707-***-****

• Vacaville, CA 95688

Qualifications Summary

Accomplished Senior Director with over 29 years of experience in clinical and commercial manufacturing, supply chain management and business operations, specializing in the biopharmaceutical sector. Efficient management of supply chain for commercial and clinical drub substance manufacturing across multiple global sites. Demonstrated success in overseeing the production and distribution processes, maintaining rigorous compliance with regulatory and quality standards. Skilled in leading cross-functional teams and building robust partnerships across manufacturing organizations to achieve operational excellence. Proven track record in driving process improvements, managing large-scale budgets, and leading strategic initiatives that enhance supply efficiency, minimize risk, and support organizational goals. Adept at fostering a culture of innovation, collaboration, and accountability within high-performing teams. Areas of Expertise

• Commercial/Clinical Manufacturing

• Clinical Supply Chain Management

• Commercial Supply Chain

Management

• Continuous Process Improvement

• Leadership & Team Development

• Inventory Optimization

• Strategic Planning & Execution

• Project Management

• Regulatory Compliance

• Coaching/Mentoring

• Learning Strategy and Execution

• cGMP Practices

• Stakeholder Relationship Management

• Data Analysis & Systems Validation

• Budget Management & Cost Control

• Risk Management & Mitigation

Career Highlights

● Spearheaded the initial start-up of Supply Chain operations at the Vacaville Manufacturing facility, developing business processes, Standard Operating Procedures, training materials, and staff recruitment. o Later led the construction, start-up and commissioning of the Weigh and Dispense facility, transitioning it to a centralized function supporting two manufacturing plants.

● Managed the transition of the Vacaville site logistics to serve as the Genentech North American hub for raw material receipt, storage, and distribution.

● Led the implementation of the company’s first ERP system, MES system, and electronic document control system.

● Functioned as Business Process Manager for Production at the Vacaville site, focusing on process health and improvements. Achieved Oliver Wight Class A certification in 2010 and facilitated the transition to SAP for the manufacturing organization.

● Implemented a site governance system at the Vacaville facility, enhancing decision-making, performance to targets, and employee engagement.

o Resulting in production performance exceeding 95%, reduced unplanned downtime, quicker product changeovers, increased run rates to 5.2 runs per week, and improved employee engagement.

● Managed multiple cost center budgets exceeding $5 million and a site CAPEX budget over $120 million, ensuring fiscal discipline and strategic capital allocation.

● Led and strategically contributed to multiple regulatory inspections (FDA, EMEA, OSHA, etc.) as area owner or response strategist, maintaining compliance and upholding industry standards. Career Experience

Senior Director, Materials Management & Business Operations, Vacaville-Technical Operations, Vacaville, CA JUL 2017 –May 2024 Served as head of the Supply Chain organization for Genentech's Vacaville Biologics Manufacturing facility, overseeing production planning, maintenance scheduling, warehousing, and logistics for the largest site in the Roche/Genentech network. Provided strategic direction for the learning management function, ensuring alignment with long-term business objectives and compliance with GMP standards. Led the site's risk management and business continuity processes, enhancing organizational resilience. Served as the site liaison for Genentech Government Relations and maintained relationships with local government and community organizations.

● Transformed the supply chain to respond effectively to volatile production changes and global supply shortages and expedited new product introductions.

● Advanced site strategy using Lean Strategy Deployment (Hoshin Kanri), aligning network, site, and departmental goals for improved leadership engagement.

Elizabeth Wentworth-Kelly

● Transitioned CAPEX portfolio management, integrating project portfolios and managing a budget exceeding $120M, achieving approximately $1.4M in savings by optimizing contract labor.

● Developed a business continuity plan for the Vacaville site, recognized as a model across North American sites, ensuring no downtime through multiple crises including COVID-19 and wildfires.

● Enhanced site-wide communications and community relations, fostering positive local perceptions and supporting corporate communication goals.

● Led transformation of site learning and development organization from transaction focused to strategic/client focused.

● Demonstrated leadership by aligning approximately 800 employees with the site's mission and fostering development for broader or higher roles within the organization.

Director Production Services, Vacaville-Manufacturing, Vacaville, CA JUL 2010 – JUL 2017 Led a team of approximately 100 employees across two manufacturing plants, managing raw material dispensing, assembly preparation, and the management of glassware and small parts. Directed a centralized organization that focused on the preparation and management of weighing, dispensing, component assembly, and handling, ensuring the supply of commercial CHO-derived products at the Vacaville Facility in compliance with safety, quality, and cGMP standards.

● Oversaw multiple cross-functional governance teams, focusing on operations and employee engagement, achieving an employee engagement score of 80% across the site and 90% within the managed function.

● Guided site leadership initiatives, including campaign and inspection readiness for successful product licensure, enhancements in facility maintenance to meet cGMP and industry standards, and improvements in workforce planning, talent development, and career growth.

● Implemented a site-wide cross-functional governance structure, optimizing operational efficiency and enhancing inter- departmental collaboration.

Senior Manager, Cell Culture, Vacaville-Manufacturing, Vacaville, CA MAR 2008 – JUL 2010 Led the cell culture organization for media preparation and small-scale cell culture (from thaw to 20L bioreactor) for commercial CHO- derived products, ensuring operations adhered to safety, quality, cGMP standards, and efficiency. Continuously evaluated and improved cell culture processes to increase efficiency, reduce costs, and enhance product yields. Collaborated with process development teams to transfer new technologies and methodologies into manufacturing.

● Unified two separate teams into a single cohesive unit, enhancing small-scale culture operations across two manufacturing plants for increased efficiency.

● Successfully executed the introduction of four products within a two-year period across both plants, demonstrating effective leadership and strategic planning in manufacturing execution.

● Acted as Business Process Manager for Production at the Vacaville site, focusing on process health and improvements. Achieved Oliver Wight Class A certification in 2010 and facilitated the transition to SAP for the manufacturing organization. Senior Manager, Materials Management Vacaville-Materials Management, Vacaville, CA JAN 2006 – MAR 2008 Lead/Senior Supervisor Materials Management, South San Francisco and Vacaville, CA JUN 1994 – JAN 2006 Education

Bachelor of Science in Physiology University of California, Davis, CA Licenses & Certifications

PharmaNet – International GMPs: Meeting US and European Requirements PharmaNet – cGMP Interpretation and Application

APICS Certification

Professional Affiliations

Board of Directors, Vacaville Chamber of Commerce

Director, Solano Economic Development Corporation

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