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Process Engineer/Analytical Dev Sp II
Vue: 130
Jour de mise à jour: 07-11-2025
Catégorie: Direction Production/Opération
Industrie: Pharmaceutical Manufacturing Chemical Manufacturing Biotechnology Research
Niveau: Mid-Senior level
Type d’emploi: Full-time
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le contenu du travail
- Our position
- Manufacturing Science, Analytical and Technology - Process Engineer Purification
- Location: GEEL
- Job type: Permanent
- About the job
The Process Engineer Purification is part of the downstream team in the Recombinant Mammalian Drug Substance (DS) function within the global Manufacturing Science and Analytical Technology (MSAT) organization and is based at the Sanofi Geel biopharmaceutical manufacturing site.
The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture based DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, dossier sections preparation, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers multiple products, modalities and expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20+ new products in next 3-5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates, synthorins and nanobodies. We are pursuing future innovations such as digital labs, factory of future and advanced analytics based process understanding and control.
Main responsibilities:
Starting from thorough scientific and technical knowledge, you contribute to Technology Transfer activities aiming at introduction of new products and processes at the Sanofi Geel biopharmaceutical manufacturing site. Additionally, you will contribute to improvement initiatives and the monitoring of existing processes at the Sanofi Geel site and within the broader Sanofi network. Your job will consist of manufacturing-scale activities, laboratory-scale activities, or a combination of both.
- Technology transfer, initial process validation (including process performance qualification) and process control strategy definition for introduction of new manufacturing processes for clinical and/or commercial manufacturing of biological drug substances.
- Identification of process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale.
- Supporting and safeguarding existing commercial production processes by data trending and monitoring, generation of scientific/technical study protocols and reports in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments.
- About you
- You have a PhD or master in Life Sciences, with relevant experience of minimum 3 years, in process development or MSAT-like functions
- Since all writing is in English and given the international context, you are fluent in writing and talking in English
- You have specific experience in protein purification on lab- and/or manufacturing scale; experience with growing mammalian cells in bioreactors is a plus
- You are flexible, willing to adapt to changing priorities and willing to learn at a rapid pace
- You are a strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
- You have an excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail
- You are familiar with various statistical and data trending techniques
- You like to work in team and consider yourself to be a good team player.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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Date limite: 22-12-2025
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