Ardena Pamplona

Susana Santesteban is QA Director and QP at Ardena Pamplona. She brings extensive experience in pharmaceutical quality systems, GMP compliance, and quality leadership across pharmaceutical manufacturing environments, including multinational companies and CDMOs. Since 2008, Susana has held leadership positions in Quality Assurance and has served as Qualified Person across different pharmaceutical organizations. Her expertise includes EU GMP and 21 CFR Part 210/211 compliance, audits, validation activities, continuous improvement projects, and the implementation of new regulatory requirements and digital quality management systems. At Ardena, she supports operational excellence and quality compliance across pharmaceutical development and manufacturing activities. Susana obtained her Bachelor’s Degree in Pharmacy from the University of Navarra and completed specialized training in Industrial Pharmacy, Quality Management, and Regulatory Affairs.

Irantzu San Martín is Project Management Director at Ardena Pamplona. She is a pharmacist with more than 20 years of experience supporting drug product development and manufacturing within CDMO environments. At Ardena, Irantzu leads Project Management, Logistics, and Warehouse operations, supporting seamless end-to-end execution of client programs. Her expertise includes coordinating cross-functional teams to deliver integrated solutions aligned with timelines, quality standards, and regulatory requirements, including GMP and FDA expectations. She is recognized for her client-focused approach and for supporting tailored and flexible solutions across pharmaceutical development programs. Irantzu obtained her pharmacy degree and completed a Master’s degree in Pharmaceutical Industry.

Iñaki Bueno is Formulation-Production and Maintenance Director at Ardena Pamplona. He is a pharmacist with more than 30 years of experience in pharmaceutical development, specializing in formulation design, process scale-up, and GMP manufacturing of innovative drug products. At Ardena, Iñaki leads formulation and production activities, supporting drug product development from pre-formulation through clinical supply and commercial readiness. His expertise includes oral solid dosage forms, pharmaceutical process transfer, Quality by Design (QbD), experimental design (DoE), and solubility enhancement technologies, including spray drying. Iñaki brings extensive technical and operational experience across pharmaceutical development and manufacturing environments, supporting efficient and compliant drug product development programs.

Beatriz Aranguren is Analytical Services Director at Ardena Pamplona. She brings more than 20 years of experience across analytical services, manufacturing, and continuous improvement within the pharmaceutical, food, automotive, and renewable energy industries. At Ardena, Beatriz leads the Analytical Services team and oversees operational performance, resource management, and customer service delivery across quality, timelines, and cost objectives. Prior to joining Ardena, she held leadership positions within the food industry, managing large-scale production operations, process optimization, safety, and cost reduction initiatives. Earlier in her career, she worked on Lean Manufacturing and productivity improvement projects for industrial companies, as well as engineering and product development activities within multinational organizations in the renewable energy and home appliance sectors. Beatriz brings extensive expertise in operational excellence, team leadership, process efficiency, and cross-functional project management across complex industrial and pharmaceutical environments.

Leyre Diez Martínez de Morentin is Packaging Group Leader at Ardena Pamplona. She specializes in secondary packaging and clinical trial supply within GMP-regulated pharmaceutical environments. Throughout her career, Leyre has developed extensive experience in the design and execution of complex packaging strategies, including double-blind and highly customized clinical trial designs. Her work focuses on supporting packaging operations across demanding clinical development programs while ensuring operational excellence and regulatory compliance. Leyre is recognized for her ability to solve complex packaging challenges and support efficient execution within dynamic project environments.

Javier Gurrea specializes in spray drying and drug product development at Ardena Pamplona. He brings around nine years of experience across pharmaceutical development and commercial manufacturing within GMP-regulated environments. Throughout his career at Ardena, Javier has held different roles supporting pharmaceutical development and manufacturing activities. He has developed strong technical expertise in spray drying, supporting the development, scale-up, and manufacturing of complex drug products across different stages of development. Javier is a pharmacist by training and obtained his PhD through research conducted at Ardena.

Carolina Cebrian specializes in Cleaning Verification Strategy at Ardena Pamplona. She brings extensive experience across pharmaceutical project management, manufacturing coordination, technology transfer, and contamination control within GMP-regulated environments. Since joining Ardena Pamplona in 2015, Carolina has worked across several functions, including Project Management, Customer Relationship Management, Manufacturing Coordination, and Technology Transfer. Her expertise focuses on Cleaning Validation, Cross-Contamination Strategy, and Molecule Categorization, with strong experience in risk assessment and contamination control within pharmaceutical manufacturing environments. More recently, she expanded her expertise through involvement in pharmaceutical quality systems within the QA area. Carolina has a background in Biochemistry and obtained her PhD in Neurosciences and Neuroimmunology. She also completed seven years of postdoctoral research at Columbia University in the United States.

Almudena Dominguez is Formulation Development and Clinical Production Group Leader at Ardena Pamplona. She brings more than 11 years of experience in drug development and manufacturing within GMP-compliant pharmaceutical environments. Her expertise focuses on oral solid dosage forms, including tablets, capsules, and granulates, across both early-stage clinical development and late-stage development programs. Throughout her career, Almudena has developed extensive experience in QbD-driven development, process optimization, scale-up, and process validation activities supporting pharmaceutical manufacturing and development programs. Almudena has a background in Chemistry and obtained a Master’s degree in Drug Development.

Marta Irurzun specializes in Analytical GMP Compliance at Ardena Pamplona. She brings extensive experience in quality control, analytical operations, and GMP-regulated pharmaceutical environments, with a strong focus on process-oriented quality and regulatory compliance. Marta began her career in the pharmaceutical industry at CINFA before joining IDIFARMA during an early stage of the company’s development, where she led the setup of the Quality Control department. In this environment, she worked closely with development teams across multiple activities, contributing to the organization’s operational growth. Following the integration into Ardena, she continued to expand her expertise within GMP analytical environments, focusing on adapting operations to regulatory requirements and supporting client audit readiness. Her experience combines analytical expertise with a broad operational perspective across pharmaceutical development and GMP compliance activities.