Our client, a biotech company in Gent, is looking for a scientist in their GMP QC Lab of the Quality Department.
You are a project lead for the GMP QC Lab. The main responsibilities are release, stability and in use testing of the pre-clinical, clinical and commercial materials under full GMP control.
- You represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert.
- You are responsible for the qualitative technology transfer of analytical methods from a Transfer Unit to the GMP Unit, or from the GMP Unit to a Receiving Unit.
- You are responsible for the establishment of GMP Analytical Methods (such as SEC, RPC, IEX-HPLC, CGE, CE-IEF, UV spectrometry, and potency assays (ELISA or cell based assays)).
- You are responsible for the establishment of technical instructions of the systems used in the GMP QC Lab.
- You perform method qualification and / or validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You perform method life cycle management and keep oversight over methods performed on different sites.
- You perform technical review of analytical results, assist and guide the (Senior) Research Associates in technical problem solving and conduct investigations if required.
- You follow up on trending data and define appropriate actions if required.
- You suggest and develop new approaches and processes.
- You organize trainings as subject matter expert (on methods, laboratory systems).
- You are responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab.
- You write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory.