1. Leslie William Stonebraker
11 Campton Place
Laguna Niguel, CA 92677
Cell: 858-405-7831
Email: stonebraker_les2@yahoo.com
Professional Profile:
• Over 15 years experience managing materials, facilities, and personnel in Logistics and Inventory
Control positions in regulated (cGMP, ISO, QSR) environments.
• Materials Department representative for resolution of all quality and regulatory issues related to
Shipping and Receiving, as well as for all regulatory and partner audits (FDA, EU, ISO, etc).
• Experienced in FDA licensing and pre-licensing audits for PLA, BLA and ELA applications.
• Effective leader supervising up to 35 department personnel.
• Extensive experience planning, forecasting, and managing CTM materials
Professional Experience:
TechLink Systems (Genentech Contractor), CA
Project Manager/Supply Chain Consultant April, 2010-present
• BioPharma materials manager and cold-chain subject matter expert assisting organization with
new product introduction per client specifications and contract deliverables.
• Managing project meetings, schedules, agendas, and project output and metrics for OCN supply
chain department resulting in successful project and new product implementation.
• Implementing best business practices using extensive experience in Bio/Pharma commercial,
medical device, and clinical Logistics/ Materials control.
Amylin Pharmaceuticals, San Diego CA
Manager, Clinical Trial Materials 2006-2009
• Managed all shipping and receiving activities for both developmental and clinical products,
resulting in high on-time delivery rate and order fulfillment accuracy.
• Supported clinical supply production planning and coordinating activities between internal
groups to ensure timely availability of supplies
• Forecasted anticipated supply needs for CTM requirements based on review of clinical protocols.
• Calculated the appropriate quantities of packaged/labeled CTM, bulk drug product, API and raw
material.
• Established IVRS specifications for re-supply and inventory management.
• Developed procedures, processes, and infrastructure to support fast growing product lines,
resulting in increased organizational efficiency and scalability.
• Participated in development and issue resolution of key management information systems,
including Oracle JD Edwards Enterprise One (E1) implementation teams, Interactive Voice
Response Systems (IVRS) validations resulting in successful implementations.
• Developed distribution, shipping, and storage strategies and plans for clinical trial materials,
including development of Cold Chain shipping and storage strategies for controlled temperature
materials.
• Ensured compliance to all regulatory requirements including SOPs, guidelines, 49 CFR, cGMP,
GCP, IATA, and OHSA.
Hospice Care for dying relative. 2004-2006
Abgenix, Inc. Fremont, CA
Sr. Manager Logistics 2002-2004

2. • Established Shipping and Receiving department at fast growing startup, resulting in policies,
procedures, and work practices consistent with industry standards and best practices.
• Ensured materials met all applicable regulations including FDA, IATA, DOT, Customs, and
USDA, and SOX resulting in successful facilities and product licensing approvals.
• Managed receipt, storage and shipment of all GMP Raw Materials, Work in Process, and Final
Product. Receipt and accountability of all Non-GMP supplies purchased on Abgenix purchase
orders.
• Directly supervised 12 department personnel.
Chiron Corporation, Emeryville, CA
Materials Manager, Finished Good and WIP 1993-2002
• Managed shipping, logistics, storage, and inventory control for three corporate divisions
including: vaccines, therapeutics, blood screening test kits, and medical devices.
• Managed numerous Cold Chain management shipping validations resulting in cost savings and
shipment reliability.
• Supervised up to 35 employees and temporary personnel as needed including two supervisors.
• Managed hazardous and biological materials handling, storage, and shipment processes with no
incidents or shipping violations.
• Participated in or facilitated FDA licensing and pre-licensing audits for PLA and ELA
applications resulting in several new product launches and approvals.
• Trained end users for SAP ERP system implementation resulting in successful system
implementation.
Syntex Labs, Palo Alto, CA
Warehouse Supervisor 1988-1993
• Supervised, coordinated and managed all daily activities of the Palo Alto production warehouse.
• Managed staging, shipping (both domestic and international), and receiving functions
maintaining inventory accuracy of all components, raw materials, and finished goods inventories
for manufacturing.
• Planned and managed distribution center inventories worldwide resulting in no stock out
situations.
• Supervised, scheduled and reviewed warehouse personnel. Maintained safety and GMP
regulations in a production environment with no safety incidents.
Computer Skills:
SAP ERP, Oracle E1/JDE, MS Office suite including MS Project, ASK/MANMAN
Education and Professional Certifications:
Management Development Certificate Program, UCSD Extension June 2007
Clinical Trials Administration Certificate Program, UCSD extension November 2008
BS Business Administration Supply Chain, University of Phoenix Expected Jan 2011
APICS CPIM Certification (in progress) 5 Module Certification Expected Sept 2010
(Have completed MRP, JIT, and Production Control modules)
Purchasing and Supply Chain Certification UCSD Extension May, 2010