Antonio Martinez

• Partners with internal functions Quality Assurance, Regulatory Affairs, Clinical Operations, Global Medical Affairs and Manufacturing/CMC as well as external groups such as CRO, CMO, Depots, and Manufacturing companies to establish project timelines and execute appropriate supply strategies.
• Executes and coordinates the procurement, and management of drug product supply and distribution activities for Phase I, II, and III clinical study trials.
• Leads supply planning forecasting activities to ensure accurate demand signals and inventory levels are incorporated into the overall supply plan, and manages supply chain risk mitigation analysis, response and implementation.
• Coordinates with the project team in the pre- project planning phase to define study requirements (documents, drug products, forms and/or ancillary labeling, if required).
• Authors and reviews label text and label design with vendors for investigational drugs used in clinical trials in accordance regulatory and quality standards.
• Leads and coordinates the trial supply storage, labeling/packaging, and distribution activities with domestic and international vendors/depots.
• Initiates and maintains budgets for CROs and vendors for clinical supply scope during the lifetime of the study.
• Manages the set-up of IRT systems (specification creation/review and UAT) along with day-to-day management of IRT (re-supply strategy creation in IRT and inventory supply).
• Manages and leads coordination of site-to-site transfers, returns for destruction, and final IP reconciliation.
• Manages and monitors shipments to clinical sites, temperature excursion, and IP Quarantine.
• Manage shelf-life expiration extension jobs at depot and coordinates relabeling activities at sites as needed.
• Manages and creates adequate import license calculations, proforma invoices, and logistics management documents.
• Leads implementation teams focused on continuous improvement of the Clinical Supply Chain processes.
• Executes RFP/RFQ process and Change Order requests to establish and maintain study budgets.
• Develops, and revises SOPs and Work Instructions in support of compliance optimization and streamlining of operations.

• Spearheaded the development, implementation, and maintenance of operations for materials management, procurement, and logistics to support a GMP facility for cell gene and virus manufacturing.
• Represented the supply chain organization as a member of the Senior Leadership Team (SLT), proposing key initiatives based on organizational priorities and capabilities.
• Ensured Master Service Agreements (MSA), Scope of Work (SOW), and Confidential Disclosure Agreements (CDA) were in place for critical suppliers.
• Oversaw the site master plan, aligning clinical manufacturing operations requirements with site resources, material needs, equipment, supplier selection, and GMP warehouse operations.
• Provided regulatory guidance on handling new product introductions, product segregation, and logistics.
• Implemented and ensured adherence to cold chain processes and procedures.
• Ensured proper tariff codes and valuations were declared on international shipments to avoid delays.
• Collaborated with the Quality organization to establish and process material specifications, Supplier Change Notifications, Supplier Corrective Action Requests (SCAR), and Vendor Complaints (VC).
• Ensured Good Documentation Practices (GDP) and timely closure of deviations and safety incident reports.
• Assessed and analyzed storage versus material demands to increase storage capacity and remove obsolete material.
• Managed and executed RFQ/RFP processes, vendor selection within Tech Ops, and sourcing support for external partners.
• Established vendor strategic relationships to reduce risks and costs, increase material availability, and streamline delivery.
• Collaborated with CMC, Tech Ops, and Quality organizations to identify materials and service needs, leading the RFQ process.
• Worked with manufacturing to establish bills of materials (BOM), PAR, and reorder level bases for forecasts.
• Designed and implemented vein-to-vein Chain of Custody/Chain of Identity traceability for autologous products (Track and Trace).
• Managed and led end-to-end clinical supply planning, ensuring uninterrupted material supply to meet schedule adherence.

• Directed and managed supply chain operations for a CAR T-Cell Therapy and Virus manufacturer, encompassing start-up operations, manufacturing support, clinical operations, commercialization, global supply chain, CMO collaboration, and logistics of GMP materials, equipment, and lab supplies.
• Oversaw Materials Management, Procurement, and Logistics departments, ensuring seamless operations.
• Ensured supplier agreements (CDA), Master Service Agreements (MSA), and Scope of Work (SOW) were in place for all critical suppliers and service providers.
• Managed EU product launch activities, including shipping validation and commercial product label creation/implementation.
• Drove continuous improvement of materials movement (pick, pack, kit, stage, ship) and storage optimization.
• Ensured on-time delivery of finished products to clinical sites by forecasting and scheduling couriers in advance.
• Established customs broker and 3PL services to enhance planning efficiency.
• Established and tracked Key Performance Indicators (KPI) and metrics in alignment with company and Tech Ops goals.
• Designed and managed the unique demands of cell therapy chain of custody (COC), chain of identity (COI), and risk mitigation.
• Ensured timely closure of change controls, deviations, and problem reports to maintain optimal supply chain flow.
• Led company optimization projects in collaboration with CMC, Technical Operations, QA, QC, and Facilities.
• Promoted an inclusive team environment to increase participation, task ownership, and shared learnings.
• Coached, trained, and developed supply chain associates to perform tasks at an optimal level.
• Communicated and endorsed safety practices by collaboratively creating safety policies applicable to all stakeholders.
• Implemented a Business Continuity Plan (BCP) for the supply chain organization to ensure uninterrupted material supply.
• Ensured CMOs adhered to service agreements for handling and shipping final products, raw materials, and forecasting.

• Led and managed start-up GMP supply chain operations to support multiple cell therapy clinical trials in preparation for regulatory auditing and commercialization.
• Managed and supported EU product launch activities, including shipping validation, commercial product label, reagent forecasting, and establishment of supplier agreements.
• Successfully led and managed the unique demands of cell therapy chain of custody (COC), chain of identity (COI), and risk mitigation of incoming starting materials and outgoing final products.
• Led and managed team projects and business unit growth and development to support multiple clinical trial products.
• Created, trained, and implemented standard operating procedures (SOP) and policies.
• Created process optimization systems in collaboration with IT to streamline supply chain processes.
• Established procedures for workflow of materials, personnel, equipment, and hazmat through GMP facility and warehouse.
• Developed and tracked Key Performance Indicators (KPI) for the supply chain organization in alignment with Tech Ops goals.
• Ensured on-time and accurate final product shipment execution to meet product infusion clinical timeline.
• Managed inventory reorder points in correlation with manufacturing volume and expiry (local and CMOs).
• Managed and oversaw receiving of incoming products to ensure COI and COC were maintained.
• Implemented cold chain logistics and storage processes and procedures.
• Streamlined procedures to ensure quality adherence and optimization of manufacturing output.
• Implemented and managed centralization of procurement, shipping, and receiving procedures for the site.
• Managed inventory cycle count program for onsite operations and CMOs.
• Championed change controls of new materials and product introductions, process changes, and non-conformance issues.
• Planned and forecasted manufacturing materials needs, kitting, and final product shipping based on trial enrollments.
• Developed and implemented comprehensive training programs for staff, increasing team productivity and expertise in material handling.
• Championed continuous improvement initiatives, driving innovation in materials management processes and tools.

• Managed the successful manufacture, inventory, and timely release of multiple client drug products by overseeing forecasting, scheduling, packaging, labeling, logistics, consignments, and materials inventory, quotations, contracts (MSA), and customer-specific quality agreements.
• Managed and led the client account management team, ensuring all client requirements were met and working in a dynamic manufacturing setting.
• Oversaw the entire product lifecycle from order request through invoice proofing and on-time delivery (OTD).
• Functioned as a combination of customer advocate, product SME, and site liaison between functional departments.
• Ensured expeditious closure of problem reports (PRs) associated with batch release to maintain OTD of the final product.
• Ensured client adherence to service agreement binding forecasts and on-time purchase order submission to secure the schedule of product manufacturing.
• Established and utilized an interactive customer CMO portal for scheduling, forecasting, and tracking of client accounts.
• Tracked batch performance metrics for all client accounts along with release and logistics KPIs of finished goods.
• Acted as a content expert of Oracle ERP end-to-end supply chain transactions and module setup.

• Managed $4 million in raw materials, $3 million in MRO spare parts, and up to $15 million in final product inventory as a multi-departmental supervisor for a 24/7 business operation.
• Served as the point of contact and regulatory audit tour lead for regulatory and CMO client GMP warehouse audits.
• Implemented and upgraded GMP inventory management systems (ERP, Oracle) conforming to GMP requirements and inventory accuracy for raw materials and MRO product contact spare parts.
• Managed multiple CMO client titled Bill of Materials ensuring accuracy for drug product manufacturing.
• Organized, supervised, and directed the work of supply chain personnel engaged in inventory control, receiving, and shipping.
• Ensured client-specific SOPs, forms, and BOMs were accurate to avoid deviations and problem reports.
• Prepared instructions regarding systems and operating procedures, training plans, and change controls.
• Analyzed production manufacturing conditions to determine present and future raw materials and spare parts needs.
• Analyzed inventory usage for all CMO clients to determine stock level reductions without sacrificing quality.
• Developed and implemented protocols and practices to streamline processes (Parts Kitting, 5S Lean, Kanban).
• Crafted appropriate strategies and implemented tactics to achieve on-time delivery objectives of final product, raw materials, and spare parts.
• Proactively managed strategic relationships with suppliers and business partners to support current and future inventory and manufacturing requirements.
• Drove continuous improvement of supplies movement, inventory accuracy, on-time delivery, and space optimization.
• Identified bottlenecks, problem areas, process gaps, and critical control points and influenced innovative solutions.
• Established improvement projects to increase performance efficiency and effectiveness.
• Worked collaboratively across multiple functions and departments within the organization to promote an inclusive culture.
• Evaluated vendor quotations for equipment and services for new product introductions, projects, and manufacturing needs.
• Evaluated and confirmed inventory accuracy cycle counts and reports.
• Led customer cGMP audit inspections for materials management GMP warehouse operations.

• Supervised and planned activities related to the PEM Group operations for a high-volume CMO agency-regulated facility.
• Supervised multi-shift storeroom technicians and buyers engaged in planning, issuing, and returning MRO spare parts.
• Managed $3 million in engineering, maintenance, and production spare parts.
• Analyzed production manufacturing conditions to determine needs for product contact and change parts availability.
• Led spare parts replacement of obsolete parts by initiating change control with specifications, blueprints, and schematics.
• Proactively managed strategic relationships with suppliers for future requirements ensuring 100% quality compliance.
• Analyzed inventory to create proposals for the destruction of excess and obsolete parts and equipment.
• Worked collaboratively across multiple departments within the organization to identify and procure critical parts.
• Maintained, planned, and printed the preventative maintenance work orders and Bill of Materials for all scheduled maintenance of facilities, packaging, and manufacturing equipment.
• Managed and planned preventative maintenance work orders and Bill of Materials kitting for scheduled facility shutdowns.
• Assigned, obsoleted, and maintained equipment and spare parts item master.

• Oversaw all activities related to the procurement of a commodity, from intent to purchase through delivery for an agency-regulated GMP manufacturing facility.
• Designed and created procurement reporting systems for better spending and cost savings of engineering projects.
• Maintained preventative maintenance work order system in ERP by planning, creating, and scheduling preventative maintenance work orders for facilities, packaging, and manufacturing equipment.
• Created and revised Bill of Materials (BOMs) for preventative maintenance work orders to ensure inventory availability.
• Planned and scheduled preventative maintenance work orders for facility shutdowns and manufacturing equipment upgrades.
• Recruited industry-known suppliers that provided high-quality parts and services.
• Reviewed purchase order requisitions and contracts for conformance with corporate procurement policy.
• Established and reviewed contracts, bids, proposals, and vendor agreements for legal correctness and price.
• Led supplier performance monitoring by creating Key Performance Indicators (KPIs) and scorecard metrics.

• Supported site equipment and facility automation upgrade activities for the world’s largest computer chip manufacturer.
• Managed the installation and removal of production equipment, ensuring seamless transitions.
• Prepared factory departmental work summaries to track and establish equipment qualification timelines.
• Determined project needs for assigned equipment decommissioning and qualification activities.
• Ensured the completion of scheduled electrical, mechanical, and chemical work orders by contractors.
• Guided contractors during the introduction of equipment into the clean room manufacturing facility to avoid interruptions in manufacturing activities.

• Performed daily technical operations in the Lithography area, moving products through all functional steps down the production line.
• Planned shift manufacturing operations, production output goals, and quality product results for the Lithography department.
• Monitored production quality trends during all steps of the manufacturing process, including MSC visual inspection, CD, and Registration of yield.
• Tracked production output to identify indications of work slow-downs or reductions in effectiveness.
• Established team coverage schedules for the functional area to support output goals.
• Performed various roles within the team, such as Team Lead, Safety Lead, Training Coordinator, and Quality Trending Monitor.