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.

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.

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.

Jacobo Artal is Production Group Leader at Ardena Pamplona. He brings experience in GMP-regulated pharmaceutical environments, specializing in solid oral dosage manufacturing and production operations.

At Ardena, Jacobo focuses on operational excellence, team performance, and continuous improvement across manufacturing activities. He combines technical expertise with a results-driven approach centered on process efficiency, operational reliability, and product quality within pharmaceutical production environments.

Jacobo brings a strong academic background together with specialized expertise in solid oral dosage manufacturing and GMP operations.

Jose Antonio Blanco is Business Unit Director at Ardena Pamplona. He brings more than 20 years of experience in the pharmaceutical industry, specializing in drug product development, manufacturing operations, and CDMO environments.

At Ardena, Jose Antonio leads site operations and cross-functional teams supporting the development and manufacturing of innovative pharmaceutical products for clinical phases. Throughout his career, he has held leadership positions across pharmaceutical manufacturing, technical operations, and business management, with extensive experience in GMP-regulated environments, process optimization, and organizational development. Before joining Ardena, he spent nearly two decades at Cinfa in operational and management roles and later served as Technical Director at Rioja Nature Pharma.

Jose Antonio has a background in Chemistry and additional academic training in Chemical Engineering. He combines technical expertise with strategic and client-oriented leadership to support pharmaceutical and biotech development 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.

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.

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.