Julio Perez Irizarry

• Serve as Technology Transfer Lead (TTL) and Project Lead for a portfolio of 15+ global Final Drug Product (FDP) technology transfer projects across Amgen manufacturing sites and Contract Manufacturing Organizations (CMOs), supporting commercialization and manufacturing network expansion initiatives.
• Lead cross-functional project teams consisting of Manufacturing, Quality, Supply Chain, Engineering, Process Development, Device Engineering, Packaging Engineering, and external partners to ensure successful project execution and site readiness.
• Develop and manage integrated project plans, schedules, governance forums, risk mitigation strategies, and communication plans to support transfer execution, milestone achievement, and launch readiness.
• Lead Make-a-Batch (MaB) assessments, process gap analyses, and manufacturing readiness evaluations to identify risks, define action plans, and support successful implementation at receiving sites.
• Own and govern key technology transfer deliverables including Process Transfer Documents, Manufacturing Process Plans, and Process Requirement Specifications, ensuring effective transfer of product and process knowledge across the manufacturing network.
• Partner with receiving-site NPI teams to coordinate manufacturing readiness, qualification, validation, and operational readiness activities supporting successful product introductions across the Amgen manufacturing network.
• Present project status, risks, mitigation plans, and critical decisions to senior leadership while coordinating activities supporting commercialization milestones and business objectives.
• Successfully led technology transfer and commercialization activities supporting products including Tezspire, Neulasta, and Otezla across AML, AOH, and external Contract Manufacturing Organizations.

• Served as Technology Transfer Lead (TTL) for global Final Drug Product (FDP) technology transfer projects supporting commercialization of biologics and combination products across the Amgen manufacturing network.
• Led cross-functional teams consisting of Manufacturing, Quality, Supply Chain, Engineering, Process Development, and external partners to support project planning, transfer readiness, and execution activities.
• Coordinated process characterization studies, risk assessments, gap analyses, and technical issue resolution to support successful transfer and implementation of manufacturing processes.
• Developed and maintained key technology transfer deliverables and supported manufacturing readiness activities to ensure effective transfer of product and process knowledge between sending and receiving sites.
• Successfully supported commercialization and technology transfer activities for products including Tezspire, Evenity, Kanjinti, Mvasi, and Avsola.

• Led characterization, validation, and implementation activities supporting inspection, labeling, and packaging operations for combination products and new product introductions.
• Authored and executed qualification protocols for automated inspection and packaging equipment, supporting equipment qualification, manufacturing readiness, and regulatory compliance.
• Provided technical leadership for equipment qualification (IQ/OQ/PQ), process verification, critical process parameter assessments, and validation activities across multiple packaging lines.
• Directed process flow design, simulation activities, and validation support for packaging processes supporting international market launches.
• Supported inspection process development and characterization activities for syringe products, driving process understanding and operational performance.

Selected for Amgen's highly competitive FUEL Emerging Talent Rotational Program, completing cross-functional rotations across Engineering (AML6 Drug Substance), Manufacturing (AML1 Final Drug Product), and Quality (AML14 Drug Product).

• Led engineering, manufacturing, and quality improvement initiatives supporting capacity expansion, operational efficiency, process reliability, and compliance performance across Drug Substance and Final Drug Product operations.
• Implemented process and reporting improvements, including manufacturing workflow optimizations and performance monitoring tools, enhancing operational effectiveness and decision-making capabilities.
• Supported Right First Time and continuous improvement initiatives, reducing process exceptions and improving manufacturing compliance and execution performance.

• Improved manufacturing process reliability through equipment optimization, preventive maintenance enhancements, and process monitoring improvements.
• Identified critical process parameters and implemented monitoring strategies to improve process robustness and reduce product loss.

• Supported new product manufacturing transfer activities, including equipment qualification, process characterization, and manufacturing readiness efforts.
• Executed Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing equipment and fixtures supporting product transfer and commercialization.
• Participated in Process Failure Mode and Effects Analysis (PFMEA) activities to identify and mitigate manufacturing risks.