Matthew Birmingham MBA CPIM

Overseeing Merrimack Pharmaceutical's internal and external supply chain operations.

Overseeing the cold chain planning, distribution, and logistics of 50+ biologic and small molecule clinical and commercial products to North America and a rapidly expanding number of international markets (Europe, Asia, and South America). Key responsibilities and accomplishments include: o Lead and manage a Distribution Center with an operating budget of $5M, representing > $3 Billion in annual revenues. o Collaborate with Customer Service, Production Planning, and Contract Manufacturers around the globe to develop and execute clinical and commercial supply plans to ensure the uninterrupted supply of products. o Successfully developed, led, and executed cold chain supply plans and strategies for multiple product launches, with all shipments occurring same day as product approval o Analyze sales forecasts, capacity requirements, master production schedules, and distribution models to develop long range distribution plans and strategies o Enhanced supply capabilities by establishing and standardizing business processes to ensure consistency in planning and execution of product supply across the network o Drive continuous improvement to enable the efficient delivery of products to customers, achieving and exceeding all Class A performance targets o Led projects to streamline distribution operations and increase throughput. No additional headcount growth over 3+ years while supply volumes increased >50% o Led the local implementation of product serialization e-Pedigree (Track and Trace) o Led effort to achieve TSA Designated Screening Area Certification. o Developed distribution strategies that streamlined carrier supply lanes, generating savings of $1M+ annually o Developed and implemented business continuity strategies and plans to mitigate supply risks o Enhanced inventory management strategies and controls (Kanban Systems, EOQ) and use of the 3PL’s o Led the development, qualification, and implementation of insulated shipping containers for cold chain products.

Led and managed the team responsible for the planning and scheduling of Production and all Non-Production (Engineering Projects, Validation, Changeover / Shutdown) activities at the Vacaville Drug Substance facility. Key responsibilities and accomplishments include: o Support Sales and Operations Planning (S&OP) process by translating aggregate product demand into valid and achievable Master Production Schedules. o Increased the team’s capability to support and manage simultaneous product-transfers by proactively leading, coaching and developing team’s ability to develop and manage SAP Master Data, resulting in 6 successful new product transfers over an 18 month period. o Led several multi-site initiatives that improved the accuracy of Material Requirements Planning (MRP) during the 0-6 month time horizon by utilizing Root Cause Analysis (RCA) to increase BOM accuracy, reduce past due orders (200% reduction), and establish processes and SAP tools to manage accuracy of schedules and MRP planning runs. o Led and managed several Governance teams to align maintenance and production activities to achieve aggressive production targets. o Led multiple efforts to achieve Class A performance levels and site certification by the Oliver Wight group. o Successfully planned and scheduled site and network material requirements to satisfy production and distribution demand, achieve agreed upon customer service levels, and realize overall inventory cost targets and objectives. o Led an international team responsible for collaboratively establishing aligned business processes for planning and scheduling across the Genentech manufacturing network.

Successfully led and managed a team (exempt, non-exempt employees and contractors) responsible for ensuring the compliant implementation and validation of all computerized systems at the Vacaville production facility. Key responsibilities and accomplishments include: - Provided direction, decision making, and quality oversight for all embedded (PLC, DCS, HMI/SCADA), non-embedded (PI Data Historian, Batch Assay History Records, BAS, DMS, LIMS, MES, etc.) systems, and computerized analytical laboratory instrumentation and equipment. - Collaboratively led the establishment of a harmonized, corporate-wide risk based validation program by developing quality standards and policies for assessing the risk of processes, systems, and equipment through the use of System Impact Assessments and Failure Mode Effects Analysis (FMEA’s). - Led multiple cross-functional projects to eliminate waste (340% reduction in cycle time) from the process by which validation protocols are reviewed and verified through the use of lean tools and methodologies (DMAIC). - Conducted product quality and lot disposition activities for the review and release of bulk API’s. - Led multiple regulatory inspection teams and actively participated in inspections and customer audits.

QA Computer Validation Lead responsible for managing projects centered on the implementation, integration, and validation of computerized systems and analytical laboratory instrumentation and equipment. Systems included: - (Multi-site Manufacturing Execution System (MES) utilizing SAP R/3 and Electronic Batch Records, Distributed Control System (DCS - Emerson Delta V), Document Management System (Documentum), Training Management System (SAP), Quality Management Systems. - Participated in the development of the company wide Project Management Program that standardized project management deliverables, processes and terminology based on the Project Management Institute Body of Knowledge (PIMBOK).

Validation Lead for the implementation and validation of information management systems (e.g. MES, DMS, CMMS) for new Large Scale international manufacturing facility. Key responsibilities included the creation of Validation Plans, Validation Test Protocols, System Specifications, Validation Summary Reports, Standard Operating Procedures, as well as integrating and harmonizing corporate and site specific procedures.

Responsible for defining, designing, and developing business solutions for emerging enterprises. Specific responsibilities and accomplishments included: - Developed, designed and implemented functionality to improve the transactional performance of one of the world’s most successful online travel vendors (Expedia.com). - Lead a team of four in the development of a resource management system designed to manage all phases of hiring and staffing.

Concentration on Information Systems, and Finance