PpAt 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. /p pAs 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. /p pWith 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. /p pBut what truly makes Ardena special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged. /p pWe 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. /p pAt Ardena, you’re not just building your career — you’re helping build the future of medicine. /p pFor the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Mariakerke (Gent, Belgium), we are looking for an /p h3ASSOCIATE DIRECTOR PRODUCTION /h3 h3YOUR KEY ROLE /h3 pAs 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. /p pYou work closely with your peer, the Associate Director Formulation Development, to receive technology transfers from RD 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. /p h3YOUR KEY RESPONSIBILITIES /h3 ul liOversee the short- and long-term planning of all non-sterile GMP Manufacturing and sterile Fill Finish GMP Manufacturing activities. /li liLead, mentor, and develop a team of GMP scientists and production operators, fostering a quality- and safety-first culture. /li liAct as the primary operational and scientific authority for GMP manufacturing, taking decisions on process-related challenges and equipment issues. /li liEnsure all manufacturing activities are executed in full compliance with GMP requirements and applicable regulatory standards. /li liReview and approve Technical Batch Reports and GMP Manufacturing Reports. /li liManage and resolve production-related issues (technical, equipment, process, quality/GMP) in a timely and risk-appropriate manner. /li liDrive continuous improvement of manufacturing processes, equipment qualification, and production efficiency. /li liEvaluate and implement new manufacturing technologies and equipment in line with business needs and regulatory expectations. /li liReceive technology transfers from the Associate Director Formulation Development team; ensure robust process understanding and GMP readiness before batch execution. /li liCollaborate closely with the Associate Director Formulation Development on project planning, resource allocation, and the RD-to-GMP handoff. /li liSupport Technical Sales by providing input on manufacturing feasibility, capacity, and timelines for new business opportunities. /li liManage HR matters for the production team: recruitment, onboarding, training, performance, and development planning. /li liActively participate as a member of the DDM-BE Management Team, contributing to strategic discussions on capacity, capability, and business growth. /li liYou report to the Business Unit Director DDM-BE. /li /ul h3YOUR PROFILE /h3 ul liPh.D. in Pharmaceutical Sciences with GMP experience, or MSc in Industrial Pharmacy. /li li7-10 years of experience in GMP pharmaceutical manufacturing, ideally within a CDMO or equivalent industrial environment. /li liSolid hands‑on GMP knowledge, preferably covering both sterile and non-sterile dosage forms. /li liAt least 2 years of relevant managerial and leadership experience in a production or manufacturing context. /li liStrong understanding of regulatory expectations for early-phase clinical manufacturing (ICH, EU GMP, etc.). /li liProven ability to lead operational teams and drive performance in a GMP-regulated environment. /li liExcellent problem‑solving skills — comfortable navigating technical and quality challenges under time pressure. /li liYou have excellent planning and organizational skills with ability to deliver work on‑time. /li liYou see things from a commercial perspective and you are customer oriented. /li liYou are flexible, stress‑resistant, solution‑oriented, and driven by a ‘make‑it‑work’ mindset. /li liExcellent communication skills in English; Dutch language skills are a plus. /li /ul h3WHAT WE OFFER /h3 ul liA true learning environment where you will have the ability to grow your skills. /li liA rapidly international developing and growing company with an interesting services, product and customer portfolio. /li liA dynamic working environment with nice colleagues. /li liOpen straightforward but also caring culture. /li liWe love creative thinking and pro‑activeness. /li liWe are true to our values. /li liAn 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. /li /ul /p #J-18808-Ljbffr