Director Analytical Development

At Ardena , we’re helping shape the future of medicine. Our teams work on the development of innovative and complex therapies that can improve the lives of patients around the world.

As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech companies to turn scientific ideas into real treatments. From early development to manufacturing and regulatory support, we help bring new medicines to market faster and with the highest quality standards.

With more than 750 colleagues across Europe and the United States, Ardena offers expertise in drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill & finish, and CMC regulatory support.

But what truly makes Ardena special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged.

We offer an international environment where you can learn, take initiative, and grow your career across teams, functions, and locations. Our way of working is guided by our CARE values: Communicative, Accountable, Reliable, and Excellent. These values shape how we collaborate, solve challenges, and support each other every day.

At Ardena, you’re not just building your career — you’re helping build the future of medicine.

For the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Ghent (Belgium), we are looking for a

DIRECTOR ANALYTICAL DEVELOPMENT  

YOUR KEY ROLE

Ardena Gent supports a global portfolio of customers in the development of innovative drug products, covering formulation and analytical development, preparation of regulatory dossiers, and GMP-compliant manufacturing and labeling of early-phase clinical materials.

Within this context, the Analytical Development function plays a critical role in the development, validation, and lifecycle management of analytical methods, as well as in the execution of quality control testing for raw materials and finished drug products. While Ardena has a strong foundation in small molecule development, the expansion into aseptic fill & finish (F&F) activities has broadened the scope to include large molecules and oligonucleotide-based therapies.

As Director Analytical Development, you are responsible for defining and executing the analytical strategy across all projects, ensuring high-quality, compliant, and scientifically robust analytical support throughout the product lifecycle. You lead and develop a multidisciplinary team of approximately 30 people, (associate) scientists and group leaders, while ensuring optimal resource planning and efficient organization of the department. In this role, you combine scientific leadership, operational excellence, and people management to drive performance and further expand Ardena’s analytical capabilities.

YOUR KEY RESPONSIBILITIES

· You define and oversee all analytical development and GMP-compliant QC activities across small and large molecule projects, ensuring scientifically sound and phase-appropriate approaches.

· You plan and organize departmental activities and resources to consistently meet or exceed targets related to quality, productivity, timelines, and capacity.

· You drive the implementation of new analytical techniques, technologies, and digital solutions, in close collaboration with validation and maintenance, to expand the service offering and improve efficiency.

· You lead, coach, and develop Group Leaders and (Associate) Scientists, ensuring clear goal setting, strong performance management and continuous team development.

· You support the professional growth of team members through structured feedback, coaching, and targeted training initiatives.

· You collaborate closely with cross-functional stakeholders (Formulation Development, Production, Quality, Project Management) to resolve issues, define priorities, and translate these into clear, actionable plans.

· You provide strategic and technical input to client proposals, defining appropriate analytical strategies aligned with project scope and regulatory expectations.

· You are a member of and contribute to the local Management Team, actively supporting site strategy, operational decisions, and continuous improvement initiatives.

· You demonstrate the ability to strategically leverage AI and digital technologies to enhance Analytical Development performance, decision‑making, and innovation. You apply AI in a compliant, data‑driven manner to improve efficiency, quality and scientific insight, while guiding your team in responsible and effective AI adoption.

· You report to the Site Head of the Drug Development & Manufacturing Business Unit.

YOUR PROFILE

· You hold a PhD or Master’s degree in a relevant scientific discipline and bring at least 10 years of experience in Analytical Development, including leadership experience.

· You have strong expertise in chromatographic techniques and dissolution, complemented by broad knowledge of physico-chemical and biological analytical methods (e.g., Karl Fischer, electrophoresis, ELISA, microbiological methods, spectroscopy).

· You have solid knowledge of CMC development and applicable regulatory guidelines (ICH, EMA, FDA, etc.).

· You have a strong quality mindset and in-depth knowledge of GMP requirements.

· You combine a customer-focused approach with a strong sense of ownership for timelines, budgets, and project delivery.

· You are proactive, flexible, and continuously seek opportunities for improvement and innovation.

· You demonstrate strong communication and reporting skills, with the ability to translate complex details into clear strategic insights.

· You thrive in a dynamic environment, effectively managing multiple priorities and stakeholders.

· You are a strong people leader with proven ability to build, align, and motivate teams across functions.

· You are proficient in MS Office; experience with Empower or similar systems is an asset.

· AI savviness

WHAT WE OFFER
· A competitive and comprehensive remuneration package, including attractive extra-legal benefits

· Opportunities for professional growth within a rapidly expanding international organization

A dynamic and collaborative working environment contributing to innovative drug development