Jobdescription
Within the Drug Substance Development (DSD) -Manufacturing department, we are looking for a "DSP ManufacturingSenior Technician " who will support the DSP large-scale operations(GMP and pilot).
You will be part of a team oftechnicians, engineers and scientists specialized in the productionand purification of recombinant proteins produced from animalcells.
You will support the DSP activities froman operational and documentation point of view : column packing,chromatography, filtrations (tangential, nano or final) for DSPoperations.
You will support theactivities related to the transfer of DSP operations to the newsite currently under construction. You will address various topicssuch as equipment, process and automation issues.
You will be responsible for :
- Performing operational DSPactivities
- Facilitating tech transfer andscaling-up
- You will be responsible for theanalysis of data, be able to present it and interact with differententities : QC, QA or with the project managers.
- Carrying out the documentation related to your function, writingprotocols, reports and procedures.
- Participating in maintaining the functionality of thelaboratories / clean rooms.
- Participating in thecontinuous improvement of the area and its activities by proposingand participating in the implementation of improvement projects.
- Participating in test activities during thequalification of process equipment in the context of corrective orimprovement changes if necessary
Qualifikationen
You have a technician diploma (CFC, HES, BTS, IUT...) with 3-5years'experience in DSP or a degree in biochemistry / biology / biotechnology or equivalentYou speak Englishand French (written and reading comprehension aplus)Knowledge of DSPprocessesKnowledge of BPF, GLP and / orGMPKnowledge of IT tools (Pack Office,Trackwise / SAP, DeltaV, MES, LIMS)You are ableto work as part of a team and have good communication skills withall stakeholders (Managers, Unit managers, scientists andtechnicians) and stakeholders from other departments (Production,QC, QA...)Ideally experience in the field ofpharmaceutical production (DSP development, clinical andcommercial)Training in Operational Excellence(LEAN, BELT) a plus