Group Leader Formulation Development

Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services. The Ardena Group is operating from five sites in Europe and one in US. For the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Mariakerke (Gent, Belgium), we are looking for aGROUP LEADER FORMULATION DEVELOPMENT & MANUFACTURING The Ardena DDM Business unit located in Belgium provide clients with a full-service solution from formulation development, analytical method development and validation, demo batch production, stability studies, clinical GMP batch production, QC testing, labelling and randomization, QP release, storage and shipping through to regulatory support for molecules in the early phase of development. In 2022 our current drug product services in oral dosage forms (granules, capsules, tablets, solutions, etc.) expanded with aseptic fill and finish (F&F) capabilities for the development and clinical production of small and large molecule injectable formulations. YOUR KEY ROLEThe Formulation and Production Team plays a key role in the development of formulations and transfer of the technology into GMP, for clinical material manufacturing.The main task of the Group Leader Formulation and Production is the planning, preparation and follow up of the assigned GMP production projects. The Group Leader Formulation and Production is responsible for the day to day management, planning and support of the Associate Scientists performing GMP production activities with the aim of facilitating progression of the activities, troubleshooting on technical and GMP compliance issues and guaranteeing that the deliverables are met within budget and time, and in accordance of the requirements of the GMP Quality system.In addition, you act as expert with respect to formulation development and GMP production activities: You function as scientific and technical problem solver in the Formulation and Production department You function as representative of the formulation and production team in project core meetings once the project enters the GMP manufacturing stage YOUR KEY RESPONSIBILITIES Lead a team of Associate Scientists Translates the input from the Project Managers to executable tasks on the work-floor Review Technical Quality Agreement and drafts the internal instructions Draft and train Master Batch Record Documentation and Batch Record Documentation templates and ensure their strict use Coordinate the purchase and the availability of starting materials prior to start of GMP Production Plan and follow up the GMP Production activities, areas and equipment Assist the Associate scientists in documenting non-conformances to guarantee the quality and compliancy Communicate with QA for follow up and strategy to be followed for non-conformances Responsible for resolving and discussing quality related issues with QA/QP Assist in the GMP Production area hands-on in case of capacity constraints Write the GMP manufacturing reports Assist in meetings with Contract Givers You report to the Director Formulation and Production YOUR PROFILE You have a PhD with scientific orientation (Pharmaceutical Sciences, Bioscience-Engineering, Science or Chemical Engineering,…) or MSc in Pharmaceutical Sciences with GMP experience You have a strong understanding of the process and preparation of different galenic forms (oral and topical dosage forms) Experience in a GMP environment is a big plus You have strong coordination and organisation skills You are able to coach and motivate the operators/scientists executing the work You have strong 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) WE OFFER An attractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance and a bonus system Ability to grow your skills in a rapidly growing company with international customer portfolio A dynamic working environment If interested, please contact us and send us your cv and motivation letter via our careersite ardena.com/careers.