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USP Manufacturing Associate Scientist (m/f/d), Corsier-sur-Vevey
Job Reference:
2bf5d61734a4
Job Views:
3
Posted:
02.04.2025
Expiry Date:
17.05.2025
Job Description:
Job Description
Within the Drug Substance Development (DSD) - Manufacturing department, we are looking for a USP Manufacturing Associate Scientist who will support the USP large-scale operations (GMP and pilot).
You will be part of a team of technicians, engineers, and scientists specialized in the production and purification of recombinant proteins produced from animal cells.
You will support the USP activities from an operational and documentation point of view: cell expansion, bioreactor process in fed-batch/perfusion.
You will support the activities related to the transfer of USP operations to the new site currently under construction, addressing various topics such as equipment, process, and automation issues.
Responsibilities:
1. Performing operational USP activities
2. Facilitating tech transfer and scaling-up
3. Analyzing data, presenting it, and interacting with different entities: QC, QA, or project managers.
4. Carrying out documentation related to your function, including writing protocols, reports, and procedures.
5. Participating in maintaining the functionality of the laboratories/clean rooms.
6. Supporting documentation activities related to your domain and compliance activities (deviations, CCP, investigations).
7. Participating in the continuous improvement of the area and its activities by proposing and implementing improvement projects.
8. Participating in test activities during the qualification of process equipment in the context of corrective or improvement changes.
9. Participating in the start-up of new equipment (qualification, validation) related to the launch of a new product.
Qualifications:
1. You have a technician diploma (CFC, HES, BTS, IUT) with 5 years of experience in USP or an Engineering/Master's degree in biochemistry/biology/biotechnology or equivalent.
2. You speak English and French (written and reading comprehension is a plus).
3. Knowledge of USP processes is a must.
4. Knowledge of BPF, GLP, and/or GMP.
5. Knowledge of IT tools (Pack Office, Trackwise/SAP, DeltaV, MES, LIMS) is a plus.
6. You are able to work as part of a team and have good communication skills with all stakeholders (Managers, Unit managers, scientists, and technicians) and stakeholders from other departments (Production, QC, QA).
7. Ideally, you have experience in the field of pharmaceutical production (USP development, clinical, and commercial).
8. Training in Operational Excellence (LEAN, BELT) is a plus.
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