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 Mariakerke (Gent, Belgium), we are looking for an

ASSOCIATE GROUP LEADER ANALYTICAL DEVELOPMENT

YOUR KEY ROLE

Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.

The analytical laboratory plays a key role in the development and validation of analytical methods to characterize drugs and to perform quality control testing on incoming raw materials and on the finished clinical materials.

In this fulltime position, you act as technical expert with respect to analytical method development and GMP QC analysis. You are the first point of contact for all analytical challenges within the company.

YOUR KEY RESPONSIBILITIES

· You are the technical expert concerning analytical method development and GMP QC analysis:

o You translate customer project goals into high-quality analytical methods

o You are the analytical expert in the project team meetings

o You function as analytical problem solver in the department

· You are responsible for the implementation of new analytical techniques in the lab in close collaboration with the engineering department

· You are responsible for the day to day management, planning and support of the (Associate) Analytical Scientists performing development and GMP analytical activities (development of methods, installation of methods, analyses of samples, validation of methods, QC release testing, GMP stability studies)

· You report to the Director Analytical Development

YOUR PROFILE

· You have a PhD, or Master’s degree with 5y of equivalent experience, in a relevant scientific discipline (Chemistry, Pharmaceutical Sciences, Bioscience-Engineering, Science or Chemical Engineering, Industrial Engineering…).

· You have profound experience in development of chromatographic analytical methods such as HPLC, UPLC, GC (and MS detection systems) and spectroscopic techniques such as UV-Vis, FTIR

· Experience in CMC method development is a plus

· Experience in a GMP environment is a plus

· You are able to run development projects independently and to keep an eye on budget and timelines

· You are able to motivate the analysts of the project team

· You have a strong interest in drug research and development and the associated analytical development.

· You are familiar with MS Office (knowledge of Empower is an asset)

· You have strong analytical and reporting skills (oral, written, presentations)

· You are a team player

· You show flexibility and you are open-minded and change oriented (always looking for ways to improve).

· AI savviness is a must

WE OFFER

· A true learning environment where you will have the ability to grow your skills

· A rapidly international developing and growing company with an interesting services, product and customer portfolio

· A dynamic working environment with nice colleagues

· Open straightforward but also caring culture

· We are true to our values

· An attractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance, 32 holidays, flexible working hours