Almudena Dominguez

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

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.

Timothy Pas

Dr. Timothy Pas is Associate Director, Formulation Development and Production at Ardena. He leads a team supporting formulation development and GMP manufacturing activities for early clinical programs.

Since joining Ardena, Timothy has progressed from Formulation Scientist to Group Leader and currently Associate Director. Throughout his career at Ardena, he has developed extensive expertise in oral and parenteral formulations, formulation development strategies, and GMP manufacturing operations supporting early-stage pharmaceutical development programs.

Timothy obtained a Master’s degree in Drug Development and earned his PhD in Pharmaceutical Technology from KU Leuven, specializing in enabling technologies and galenic principles.

Seppe De Smet

Seppe De Smet is Director of Analytical Development. He leads the definition and execution of analytical strategies supporting drug product development across the full product lifecycle at Ardena. He focuses on aligning scientific, regulatory, and client needs through phase-appropriate analytical approaches, control strategies, and lifecycle management.

Throughout his career, Seppe has supported programs from preclinical development through clinical stages and commercialization, providing end-to-end analytical oversight tailored to each phase of development. He has worked across both CRO and biotech environments, combining project leadership with scientific expertise in small molecules and biologics. His experience includes method development, validation, GMP-compliant analytical operations, regulatory submissions, and CMC-related processes including manufacturing, quality control, and release testing.

Seppe earned his PhD in Analytical Chemistry with a strong focus on chromatography. At Ardena, he supports clients through high-quality and pragmatic analytical solutions designed to accelerate development timelines while ensuring product quality and regulatory compliance.

Raja Yekkala

Dr. Raja Yekkala is Business Development Director at Ardena. He brings more than 20 years of experience across pharmaceutical sciences, CMC development, analytical sciences, drug product development, clinical supply, and manufacturing support.

At Ardena, Raja focuses on strategic business development for integrated pharmaceutical development and manufacturing programs in both human and veterinary applications. He supports clients throughout the full development journey, from early-stage activities through clinical phases, working closely with multidisciplinary teams across formulation development, analytical development, GMP manufacturing, regulatory affairs, project management, and clinical supply. His expertise includes comparator sourcing strategies, clinical trial supply planning, and the coordination of complex clinical supply programs supporting global development activities. Over the course of his career, he has contributed to bringing several dozen compounds into clinical development. Prior to transitioning into business development leadership roles, Raja held scientific and project management positions at Ardena and Pharmavize, where he managed complex CMC programs, clinical supply manufacturing activities, and cross-functional development projects. Earlier in his career, he worked as a research scientist at KU Leuven, contributing to pharmaceutical analysis, method development, and pharmacopoeial monographs adopted by the WHO.

Raja is a pharmacist by training and obtained his PhD in Pharmaceutical Chemistry and Drug Analysis from KU Leuven, Belgium. He is author and co-author of multiple peer-reviewed scientific publications, contributor to internationally recognized pharmacopoeial monographs, and co-inventor of a patent related to pharmaceutical formulation technologies.

Annelies Paridaens

Annelies Paridaens is Director of Project Management at Ardena Ghent. She brings extensive experience in clinical supply and a strong track record in managing complex pharmaceutical development programs.

At Ardena, Annelies focuses on ensuring efficient project execution, aligning stakeholder expectations, and maintaining high quality standards across development activities. She is known for her structured approach, pragmatic leadership style, and clear communication, as well as her ability to navigate complex technical and regulatory challenges. She works closely with internal stakeholders and international clients, translating technical requirements into clear project strategies and fostering collaborative partnerships.

Annelies is committed to supporting the efficient advancement of innovative therapies and contributing to Ardena’s mission of accelerating the path from molecule to medicine.

Daan Vanhaecke

Daan Vanhaecke is Group Leader for Formulation Development and Production at Ardena. As an industrial pharmacist, he combines hands-on technical expertise with a structured and quality-driven approach across GMP manufacturing and pharmaceutical development environments.

Prior to joining Ardena, Daan built experience across several pharmaceutical companies, contributing to equipment qualification for ATMP manufacturing and Quality Assurance oversight activities. At Ardena, he is responsible for the day-to-day management of GMP production projects and associate scientists, including troubleshooting technical and GMP compliance challenges to ensure projects are delivered on time, within budget, and in compliance with cGMP standards.

Daan brings experience across both QA and manufacturing environments and works closely with internal stakeholders and clients to support the successful development and production of innovative therapies.

Laure Descamps

Laure Descamps is Senior Formulation Scientist at Ardena, specializing in solid dosage development and process understanding. She supports formulation design, process optimisation, and early-phase drug product development for complex pharmaceutical programs.

At Ardena, Laure applies her expertise to developing robust formulation strategies that support the efficient advancement of complex molecules toward clinical evaluation. Her work focuses on formulation development and process understanding across early-stage drug product development activities.

Laure obtained her Master’s degree in Drug Development and Industrial Pharmacy and earned her PhD from Ghent University’s Laboratory of Pharmaceutical Process Analytical Technology. Her doctoral research focused on tabletting behaviour, material characterisation, and compression challenges in collaboration with industry partners.

Sander Delahaye

Sander Delahaye is Group Leader in Analytical Chemistry at Ardena Ghent. He brings extensive expertise in analytical method development, validation, and lifecycle management within GMP-regulated pharmaceutical environments, with a strong focus on chromatographic techniques and physicochemical analysis.

Prior to joining Ardena, Sander worked at Ajinomoto OmniChem as Group Leader in Analytical Development, supporting the development and commercial manufacture of active pharmaceutical ingredients (APIs). During this time, he built extensive expertise in analytical method development and validation in accordance with ICH guidelines, with technical experience spanning GC, HPLC/UHPLC, and orthogonal analytical techniques, including Karl Fischer titrations. He also played a key role in GMP release testing, as well as the validation and troubleshooting of analytical methods for large-scale synthetic processes. After a decade focused on API analytical development, he transitioned to Ardena to broaden his expertise toward drug product development, supporting formulation development, release testing, and stability studies for clinical trial materials.

Sander obtained his Master’s degree in Chemistry from Ghent University, followed by a PhD specializing in separation sciences. His doctoral research focused on the fundamental principles of supercritical fluid chromatography (SFC) and contributed to the understanding and optimization of this technique for complex analytical applications.

Ardena Somerset

About This Facility

Welcome to Ardena Somerset

Ardena Somerset is our US center of science and manufacturing – and it does more than most CDMO sites its size. The facility houses 200+ scientists, engineers, and operations specialists serving as a Center of Excellence for advanced oral dosage forms, including hot melt extrusion and solubility enhancement for poorly soluble drugs. FDA registered, DEA licensed, and cGMP compliant, it supports late-stage and small-scale commercial manufacturing for controlled substances and complex molecules.

In April 2026, Ardena opened a new state-of-the-art bioanalytical laboratory at Somerset — 2,500+ sq ft of operational lab space with LC-MS/MS systems, immunochemistry platforms, and controlled sample storage. The lab supports quantitative analysis for preclinical and clinical studies across small molecules, biologics, ADCs, and biomarker programs, bringing Ardena’s European bioanalytical depth directly to North American clients. Additional platforms including qPCR and flow cytometry are being added in the coming months.

Two capabilities. One site. Coordinated by scientists who own innovation.

Facility Details

Address

14 School House Road 08873 Somerset, United States (732)  231-2201

Employees

200+

Certifications

FDA registered DEA licensed cGMP compliant

Services

Bioanalysis Drug Product Hot Melt Extrusion