Senior Director, Insights and Analytics – Immunology (Non-Alliance)

About the Job

Sanofi Manufacturing and Supply Organization is preparing its future through an ambitious program named Modulus. The Modulus 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 biological products. One of these two Modulus is implemented in Singapore in a new Greenfield site, with a design similar 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.

Manufacturing Science, Analytics and 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 Modulus Singapore is seeking an upstream Senior Engineer I to provide technical expertise for upstream 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.

Duties & responsibilities

Process transfer & validation:

• Upstream 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 MSAT technical perspective and main author for MSAT documentation in upstream 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 and propose & own improvement activities, including working cross-functionally within the site and network.

• Support/Lead site-level projects involving key process changes.

• Develops upstream MSAT technical documents during process improvements.

• Is (or work towards) a domain expert at site, or network key opinion leader.

• May mentor junior coworkers.

Pre-requisites

• 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.

• 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.