Senior Engineer I, MSAT (Downstream)
Sanofi Manufacturing and Supply Organization is preparing its future through an ambitious program named EVolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two EVF is implemented in Singapore in a new Greenfield site, with a design identical to the one in Neuville (France). Our manufacturing sites are state-of-the-art, powered by big data and digital. It is the bridge between scientific advances and transformative medicines and will be serving millions of people around the world.
The Manufacturing Science and Analytical Technology (MSAT) drives the industrialization and the improvement of biological processes and products. It embarks new technologies and digital trends. It is the keeper of manufacturing process knowledge. MSAT is at the crossroad of R&D and production. It is a multi-disciplinary function that provides expertise in process, manufacturing sciences, process modeling, statistical analysis, process validation and technology transfer.
The MSAT team in Sanofi EVF, Singapore is seeking to expand the team and has two open positions as MSAT Senior Engineer specialized in Upstream and Downstream biological processes. The successful applicant/s for this position will be joining the MSAT team located in Sanofi EVF, Tuas Singapore. The purpose of this role is to provide technical expertise for Upstream and Downstream processes areas in various activities like new product introduction, technology transfer, shopfloor support for manufacturing runs and to support troubleshooting activities at manufacturing scale.
- In this role, you will act as SME for Downstream processes to provide scientific/technical expertise during the project startup phase and as well as during the routine manufacturing.
- Provide technical support during project startup phase with respect to process equipment, process mass balances, commissioning qualification and validation activities, designing single use assemblies and defining MES workflows.
- Possess a strong understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
- Work closely with the internal MSAT Process Leads to facilitate technology transfer of new products, support in defining manufacturing processes, establishing process control strategy and developing process validation strategies.
- Lead/participate as SME in process risk/gap assessments, investigations, deviations, change controls and CAPA implementation in support of new product introduction and during routine manufacturing operations.
- Provide shopfloor support for successful implementation of biological products during technical runs, process validation runs and commercial batch runs.
- Generate technical documents (memos, protocols, reports, plans, etc.,) related to technology transfer, process monitoring, process improvements, etc.
- Work cross-functionally with cross functional teams and the teams across sending unit to develop manufacturing processes to enhance and optimize overall production.
- Bachelor of Science degree or higher, preferably in Biotechnology, Biological Sciences, or Chemical Engineering.
- Minimum 3 years of work experience in Upstream or Downstream biological processes in a cGMP Biopharmaceutical facility.
- Previous work experience with mammalian cell culture would be desirable and experience with continuous manufacturing such as perfusion cell culture, continuous chromatography would be an advantage.
- Previous experience in technology transfers, manufacturing support, process validation in a clinical/commercial facility.
- Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based business decisions.
- Effective communication skills necessary to interact with internal stakeholders (includes strong presentation skills).
Sanofi Behaviours such as Stretch, Take Action, Act for Patients and Customers and Think One Sanofi are required to be demonstrated in this position.
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.