Jobdescription
Within the Drug Substance Development (DSD) -Manufacturing department, we are looking for a "USP ManufacturingAssociate Scientist " who will support the USP large-scaleoperations (GMP and pilot).
You will be part of ateam of technicians, engineers and scientists specialized in theproduction and purification of recombinant proteins produced fromanimal cells.
You will support the USPactivities from an operational and documentation point of view:cell expansion, bioreactor process in fed-batch/ perfusion.
You will support the activities related tothe transfer of USP operations to the new site currently underconstruction. You will address various topics such as equipment,process and automation issues.
Youwill be responsible for:
- Performingoperational USP activities
- Facilitating techtransfer and scaling-up
- You will be responsiblefor the analysis of data, be able to present it and interact withdifferent entities: QC, QA or with the projectmanagers.
- Carrying out the documentationrelated to your function, writing protocols, reports andprocedures.
- Participating in maintaining thefunctionality of the laboratories/clean rooms.
-Supporting documentation activities related to your domain as wellas compliance activities (deviations, CCP,investigations...).
- 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
- Participatingin the start-up of new equipment (qualification, validation)related to the launch of a new product.
Qualifikationen
-You have a technician diploma (CFC, HES, BTS, IUT...) with 5years'experience in USP or an Engineering/ Master's degree inbiochemistry/biology/ biotechnology orequivalent
- You speak English and French(written and reading comprehension a plus)
-Knowledge of USP processes is a must
- Knowledgeof BPF, GLP and/or GMP
- Knowledge of IT tools(Pack Office, Trackwise/ SAP, DeltaV, MES, LIMS) is aplus
- You are able to work as part of a team andhave good communication skills with all stakeholders (Managers,Unit managers, scientists and technicians) and stakeholders fromother departments (Production, QC, QA...)
-Ideally experience in the field of pharmaceutical production (USPdevelopment, clinical and commercial)
- Trainingin Operational Excellence (LEAN, BELT) aplus