Fully digitalized, our Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people's lives by giving them faster access to more treatments.

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 a Senior Engineer II to provide technical expertise for upstream and downstream biological process areas in various activities like new product introduction, technology transfer, shopfloor support and troubleshooting activities at manufacturing scale, as well as lead process investigations. The MSAT Senior Engineer II is expected to lead complex and/or multi-step deviations & CAPA plans, and can be consulted by Manufacturing leads for complex equipment & operational workflows, and/or those with high interdependency. This role also provides coaching to junior members of the MSAT and manufacturing teams, and can specialize to become a network SME/KOL.

Main responsibilities

Process transfer & validation

• Upstream and downstream SME to provide scientific/technical expertise including process equipment, process mass balances, process validation and process design & control.
• Work closely with MSAT DS leads to facilitate technology transfer of new molecules, including defining manufacturing processes, establishing strategies behind process validation and process control.
• Author complex or multi-process step MSAT technical documents (e.g. memos, protocols, reports, plans) during process transfer & validation phase and process monitoring.
• Build and promote systems and tools for (i) standardization concepts & implementation, (ii) sharing and retention of design knowledge, within site and Sanofi network.

Manufacturing support

• Provide upstream and downstream MSAT technical perspective and main author for MSAT documentation in complex or multi-process step situations such as change controls, impact assessments and memos.
• Provides consultation to manufacturing coworkers from scientific and technological perspectives.
• In process disruptions, serve as secondary shopfloor escalation contacts. For complex/process-related investigations, independently lead process risk/gap assessments, investigations, change controls & CAPA implementation. Is part of after-hours MSAT on-call system to support manufacturing disruptions.

Molecule lifecycle management & yield improvement activities

• Identify trends, assess potential causes and propose & own improvement activities, including working cross-functionally within the site and network.
• Lead site-level projects involving key process changes. May lead network-level projects.
• Develops complex or multi-process step MSAT technical documents during process improvements.
• Is (or work towards) a domain expert at site, or network key opinion leader.
• May mentor junior MSAT coworkers as well as manufacturing colleagues.

About You

Knowledge, skills & competencies
• An effective communicator and productive in multi-functional & multi-cultural communication settings.
• Has excellent analytical, consultative and diagnostic skills with ability to make sound, data-based business decisions.
• Self-directed and comfortable working with a high level of autonomy, for initiating activities to close gaps and complete assigned tasks.
• Data-driven and scientifically curious.

Qualifications & requirements

• Holds a scientific or engineering degree (or higher), preferably in Biotechnology, Biological Sciences, or Chemical Engineering.
• Has more than 8 years of broad industrial experience in biopharmaceutical projects, particularly in technology transfers, process validation and manufacturing support.
• Possesses strong understanding of critical processes/operations as well as interactions between different process parameters.
• Has hands-on experience in pilot-scale or large-scale facilities, of cell culture and/or purification techniques.

• Is familiar with cGMP concepts in biopharmaceutical environments and up-to-date with regulatory requirements and industry best practices.

Play-to-Win behaviors
• Stretch to go beyond the level we have operated at up until now
• Take Action instead of waiting to be told what to do
• Act in the interest of our patients and customers
• Think One Sanofi: we put the interest of the organisation ahead of ourselves or our team