Ardena Somerset

Nearly 20 years (17 to be exact!) of experience in life sciences and CDMO as well as healthcare packaging supporting both operational and commercial transformations in highly regulated environments. Lead multiple site transformations, embedding lean methodologies and employing a better every 30 days approach for internal and external stakeholders. Customer focused and solutions oriented leader with a passion for developing future leaders in Publicly traded and Private Equity organizations.Most recently served as VP, Operations at Amcor Healthcare Division leading seven (7) sites and spent 15 years prior with Catalent across small and large molecule supply of critical medications. Holds a Master of Science (MSc) in Bioengineering from the University of Nottingham.

Mira Mikhael is Supply Chain Planning Group Leader at Ardena Somerset. She is responsible for supply chain and production planning activities, supporting operational readiness and project execution across the site. Mira began her career in a small biotech company before joining Catalent’s GOLD leadership development program, where she completed rotations across Quality Assurance, Analytical Development, and Manufacturing. Following the program, she advanced to the role of Manufacturing Supervisor in Somerset, where she led ERP implementation activities following a site acquisition. Throughout her career, she has developed expertise in manufacturing operations, production planning, and supply chain coordination within pharmaceutical development and manufacturing environments. Mira obtained her Bachelor of Engineering degree in Biomedical Engineering and earned her Master of Science in Pharmaceutical Manufacturing from Stevens Institute of Technology. In addition to her operational responsibilities, she hosts Ardena’s Galenic podcast, helping connect colleagues across the organization through discussions focused on learning and professional development.

Ian joined Ardena in 2025 as US Managing Director.  He has over 30 years of global experience across multiple functions in both the CDMO and Medical device industry.   Ian spent 19 years of his career working at GE in Quality, Finance, Supply Chain, Technical services and Commercial operations.   He then joined Catalent in 2013 where he was VP of Sales Operations and more recently GM for the Somerset site.  He holds degree in Mechanical Engineering and an MBA from Northwestern University – Kellogg School of Management.

Paul Edwards joined Ardena in 2026 as Chief People Officer, bringing over 30 years of international Human Resources leadership across complex, science-driven and global organisations. Paul has extensive experience in shaping people strategy to support organisational growth and transformation, most recently serving in senior HR leadership roles at Catalent Pharma Solutions.

Shelly Koonce is Director of Human Resources at Ardena. She brings more than 25 years of experience across the defense and aerospace, academia, pharmaceutical, and consumer goods industries. Throughout her career, Shelly has developed extensive expertise as a people and business partner, supporting talent development, organizational leadership, and cross-functional collaboration within complex business environments. Her leadership approach is grounded in collaboration and authenticity, with a strong focus on building partnerships and supporting employee growth and engagement across the organization. At Ardena, she works closely with leaders to foster an environment where individuals are empowered, recognized, and supported in reaching their full potential. Shelly obtained her Master’s degree in Human Resources Development and Leadership.

Stephen Csernica is Associate Director of Formulation Development at Ardena. He brings extensive experience in solid oral formulation development, with expertise spanning solubility enhancement and complex extended-release technologies. Throughout his career, Stephen has developed expertise across end-to-end pharmaceutical development, CMC compliance, and formulation development activities supporting complex drug product programs. He also has experience leading high-functioning teams within pharmaceutical development environments. Stephen obtained his PhD in Chemical Engineering from Lehigh University in 2013.

Kathleen Reyf is Director of Project Management at Ardena Somerset. She oversees project execution and customer experience across development and commercial programs, supporting successful delivery throughout the product lifecycle. Kathleen brings more than 20 years of experience across the pharmaceutical industry. She began her career as a Microbiologist and later became a certified Lean Six Sigma Black Belt, leading continuous improvement initiatives before transitioning into project management. With more than 10 years of project management experience, she has led high-performing teams supporting product development, validation, and commercialization across multiple oral solid dosage technologies. Kathleen obtained her Bachelor of Science degree in Biology and combines operational, technical, and project leadership expertise to support successful pharmaceutical development and manufacturing programs.

Ajitkumar Dangar is Associate Director of Analytical Research & Development at Ardena Somerset. He brings more than 26 years of experience across analytical sciences, quality control, CMC development, and CRO operations within the pharmaceutical industry. Throughout his career, Ajitkumar has built and led high-performing teams and supported complex pharmaceutical development programs focused on small molecules. His expertise spans analytical research and development, quality control operations, and CMC activities supporting pharmaceutical development programs. Ajitkumar obtained his Master of Science degree in Organic Chemistry in 1999.

Ana Freire Salinas is Finance Director for the Drug Product sites across Pamplona, Ghent, and Somerset within the Ardena Group. She brings more than 15 years of experience in finance leadership roles within the pharmaceutical and biotech industry. Throughout her career, Ana has led major financial transformation initiatives, including post-acquisition integrations, ERP implementations, and the development of group reporting and controlling frameworks. At Ardena, she leads cross-functional finance teams across multiple international sites, supporting financial operations and organizational alignment across the business. In parallel, she has also served as a lecturer at the University of Navarra for more than 15 years. Ana obtained her Executive MBA from ESIC Business & Marketing School and earned her bachelor’s degree in Business Administration from the University of Navarra.

Hibreniguss (Hibre) Terefe, PhD, is Director of Product Development and Site Head of R&D at Ardena Somerset. He leads integrated preformulation, formulation R&D, and analytical R&D teams supporting drug product development programs from early-stage enabling technologies through Phase III and commercial launch. Hibre brings more than 20 years of pharmaceutical industry experience in oral drug delivery systems and drug product development. His expertise includes hot melt extrusion, solubility enhancement, amorphous solid dispersions, modified release technologies, pediatric formulations, and abuse deterrent platforms. Throughout his career, he has combined scientific expertise with strategic and organizational leadership to support efficient and milestone-driven development programs. He is also recognized as an industry thought leader in oral drug product development and CMC strategy, with more than 15 publications across industry and scientific journals, contributions to the Handbook of Pharmaceutical Granulation Technology, and involvement as co-inventor on 10 patents and patent applications related to drug delivery technologies. Hibre obtained his pharmacy degree and earned his PhD in Pharmaceutical Chemistry, with an emphasis in Analytical Chemistry, from Westfälische Wilhelms-Universität Münster, Germany. He also served as a Fulbright Visiting Scholar at the University of California, Berkeley.

Joseph Ju is Director of Continuous Improvement at Ardena Somerset. He brings more than 13 years of experience in the CDMO pharmaceutical manufacturing industry, with expertise spanning cGMP clinical and commercial manufacturing operations, process optimization, and operational excellence. At Ardena, Joseph oversees cGMP clinical and commercial manufacturing operations in Somerset, focusing on continuous improvement initiatives and scalable manufacturing performance. Throughout his career, he has led commercial operations teams supporting operational efficiency and sales growth within regulated pharmaceutical manufacturing environments. Joseph obtained both his Master of Science and Bachelor of Science degrees in Biomedical Engineering from the New Jersey Institute of Technology.

Phillip Santos is Engineering Director at Ardena Somerset. He brings more than 20 years of experience in the pharmaceutical industry, with expertise spanning process equipment, facilities management, and GMP manufacturing across multiple small molecule dosage forms. Throughout his career, Phillip has built and led high-performing engineering teams and supported complex programs within regulated manufacturing environments. At Ardena, he is responsible for engineering operations across the Somerset site, supporting operational efficiency and manufacturing activities within GMP-regulated environments. Phillip is recognized for his leadership in engineering operations and his experience managing technical and operational activities across pharmaceutical manufacturing facilities.

Peggi Gosha is Director of Supply Chain at Ardena Somerset. She brings more than 23 years of experience across medical device manufacturing and the pharmaceutical industry, with expertise in supply chain operations within regulated manufacturing environments. Throughout her career, Peggi has focused on building scalable and compliant processes that support inventory control, operational efficiency, and cross-functional alignment. At Ardena, she leads supply chain strategy for the Somerset site, supporting GMP operations and the expansion of bioanalytical services. Peggi is recognized for driving strategic initiatives, implementing structured systems, and supporting audit-ready operations within highly regulated environments.

Neil Eppinger is Interim Associate Director of Analytical Services at Ardena Somerset. He brings more than 20 years of experience in pharmaceutical quality, specializing in microbiology and controlled environments within cGMP-regulated clinical and commercial manufacturing facilities across diverse product portfolios and cleanroom classifications. In his current role, Neil leads analytical and microbiological quality control programs, including environmental monitoring, stability and sample coordination, cleaning verification and validation, and contamination control strategies. Throughout his career, he has supported regulatory inspections conducted by the FDA and international agencies and has performed quality inspections of suppliers and intercompany sites. He also brings extensive experience conducting complex microbial investigations to ensure compliance with global regulatory standards. Neil is recognized for his leadership of cross-functional teams, commitment to data integrity, and focus on risk-based quality strategies that support continuous improvement, operational excellence, and patient safety.