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
YOUR KEY ROLE
As Associate Director Production, you lead the GMP manufacturing operations for early-phase clinical materials at Ardena Gent, covering both non-sterile and sterile (Fill & Finish) manufacturing. You are responsible for the planning, execution, and quality compliance of all GMP production activities, ensuring that clinical batches are delivered safely, on time, and in full conformance with applicable GMP standards.
You work closely with your peer, the Associate Director Formulation Development, to receive technology transfers from R&D and translate formulations into robust, scalable GMP processes. Together, you contribute to the strategic development of the DDM-BE business unit. The Formulation Development & Production department is one department with two distinct leaders.
YOUR KEY RESPONSIBILITIES
- Oversee the short- and long-term planning of all non-sterile GMP Manufacturing and sterile Fill & Finish GMP Manufacturing activities.
- Lead, mentor, and develop a team of GMP scientists and production operators, fostering a quality- and safety-first culture.
- Act as the primary operational and scientific authority for GMP manufacturing, taking decisions on process-related challenges and equipment issues.
- Ensure all manufacturing activities are executed in full compliance with GMP requirements and applicable regulatory standards.
- Review and approve Technical Batch Reports and GMP Manufacturing Reports.
- Manage and resolve production-related issues (technical, equipment, process, quality/GMP) in a timely and risk-appropriate manner.
- Drive continuous improvement of manufacturing processes, equipment qualification, and production efficiency.
- Evaluate and implement new manufacturing technologies and equipment in line with business needs and regulatory expectations.
- Receive technology transfers from the Associate Director Formulation Development team; ensure robust process understanding and GMP readiness before batch execution.
- Collaborate closely with the Associate Director Formulation Development on project planning, resource allocation, and the R&D-to-GMP handoff.
- Support Technical Sales by providing input on manufacturing feasibility, capacity, and timelines for new business opportunities.
- Manage HR matters for the production team: recruitment, onboarding, training, performance, and development planning.
- Actively participate as a member of the DDM-BE Management Team, contributing to strategic discussions on capacity, capability, and business growth.
- You report to the Business Unit Director DDM-BE
YOUR PROFILE
- Ph.D. in Pharmaceutical Sciences with GMP experience, or MSc in Industrial Pharmacy
- 7-10 years of experience in GMP pharmaceutical manufacturing, ideally within a CDMO or equivalent industrial environment.
- Solid hands-on GMP knowledge, preferably covering both sterile and non-sterile dosage forms.
- At least 2 years of relevant managerial and leadership experience in a production or manufacturing context.
- Strong understanding of regulatory expectations for early-phase clinical manufacturing (ICH, EU GMP, etc.).
- Proven ability to lead operational teams and drive performance in a GMP-regulated environment.
- Excellent problem-solving skills — comfortable navigating technical and quality challenges under time pressure.
- You have excellent planning and organizational skills with ability to deliver work on-time
- You see things from a commercial perspective and you are customer oriented
- You are flexible, stress-resistant, solution-oriented, and driven by a 'make-it-work' mindset.
- Excellent communication skills in English; Dutch language skills are a plus.
WHAT 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 love creative thinking and pro-activeness
- We are true to our values
- An attractive and tailor-made remuneration package including extra-legal benefits such as: company car, group insurance, hospitalization insurance, meal vouchers, eco vouchers and a group bonus system
