GROUP LEADER ASEPTIC MANUFACTURING (GHENT)

Consultancy

Information

The Group Leader Aseptic Manufacturing / Fill & Finish will be responsible for the start up of our GMP fill and finish activities. This includes the set-up and drafting of process flows for aseptic manufacturing, validation of the aseptic filling workflow (media fills) and training of the associate scientists. Together with the colleagues of the QA department, you will ensure that the full process is in line with the GMP Annex 1 requirements. Once the fill & finish activities are up and running, You will operate as Group Leader F&F. The main task of the Group Leader F&F is planning, preparation and follow-up of the assigned Fill & finishprojects from initial formulation development up to GMP production. Furthermore, the Group Leader F&F is responsible for the day to day management, planning and support of the (associate) scientists performing formulation and 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. - You have a PhD with scientific orientation (Pharmaceutical Sciences, Bioscience-Engineering, Science or Chemical Engineering, …) or equivalent by experience - You have hands-on experience with the preparation of aseptic productions and knowledge of the process - Experience in a GMP-like environment is mandatory - Experience in formulation development for sterile solutions (small or large molecules) is an asset
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