Job title: Senior Engineer I, Manufacturing Science and Analytical Technology (MSAT)
Location: Singapore
Hiring Manager: Head of Manufacturing Technology, EVF
About the job:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Sanofi has added two new Evolutive Facilities to our global industrial footprint. These production units (EVF) represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.
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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 an upstream/downstream Senior Engineer I to provide technical expertise for upstream/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 I is expected to lead deviations & CAPA plans, and can be consulted by Manufacturing leads for equipment & operational workflows. This role can specialize to become a network SME/KOL.
Main responsibilities
Process transfer & validation
- Upstream or downstream SME to provide scientific/technical expertise including process equipment, process mass balances, process validation and process design & control.
- Work closely with receiving unit MSAT DS leads as well as sending unit teams to facilitate technology transfer of new molecules, including defining manufacturing processes and workflows, establishing strategies behind process validation and process control.
- Author upstream or downstream 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 or downstream MSAT technical perspective and main author for MSAT documentation in upstream or downstream process 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, including leading 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 andpropose & own improvement activities, including working cross-functionally within the site and network.
- Support/Lead site-level projects involving key process changes.
- Develops upstream or downstream MSAT technical documents during process improvements.
- Is (or work towards) a domain expert at site, or network key opinion leader.
- May mentor junior coworkers.
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
- Holds a scientific or engineering degree (or higher), preferably in Biotechnology, Biological Sciences, or Chemical Engineering.
- Has more than 5 years of broad industrial experience in biopharmaceutical projects, particularly in technology transfers, process validation and/or 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 Behaviours
- 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