Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

• Position title: Material Specialist II, MSAT

• Reporting to: Head of Manufacturing Technology, EVF

• Location: Modulus, Tuas Singapore

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 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 Modulus Singapore is seeking a MSAT Material Specialist to execute strategies of single use systems and raw materials during project startup, process validation as well as routine manufacturing. The Material Specialist will support material qualification activities and from a site process technical expert perspective, ensuring process materials meet quality and compliance requirements for both upstream and downstream processes. The Material Specialist will work under the guidance of the MSAT Material Expert while collaborating with internal stakeholders.

Performance Standards: Duties & Responsibilities

Single use systems (SUS) & raw materials (RM) in bioprocess designs

• Support site material council activities.

• Assist the selection and implementation of RM and SUS for site- and molecule-specific usages in both upstream and downstream processes.

• Contribute to and promote systems and tools for standardization and knowledge retention within the site.

• Support preparation of MSAT technical documents relating to material sciences including extractable and leachable assessments while ensuring regulatory compliance.

• Supports site-level projects involving key process material changes. May lead site projects.

• Develop technical knowledge in SUS applications for both upstream and downstream processes.

SUS & RM qualification & control

• Execute activities for material onboarding and documentation readiness, in both upstream and downstream processes.

• Execute RM & SUS qualification and control strategies aligned within Material Council, such as user requirements material specifications, and MSAT technical documents for process validation studies, shake-down and engineering runs.

• In process disruptions, participates in complex/ lead straightforward material-related investigations from a scientific perspective. May be part of after-hours MSAT on-call system to support manufacturing disruptions.

SUS & RM in molecule lifecycle management

• Support material readiness activities for both upstream and downstream processes.

• Contribute to MSAT documentation in supplier/material change management and new material introduction, such as change controls, impact assessments and memos.

• Work with procurement, supply chain and manufacturing by supporting LCM initiatives including CoGS reduction, supply continuity plans.

Pre-requisites

Knowledge, Skills & Competencies

• Good communication skills and ability to work in multi-functional & multi-cultural communication settings.

• Detail-oriented with ability to follow established procedures and protocols.

• Data-driven and scientifically curious.

Qualifications/ Requirements

• Holds a scientific or engineering degree (or higher), preferably in Biotechnology, Biological Sciences, or Chemical Engineering.

• Has experience in biopharmaceutical environments including RM and SUS applications.

• Preferably 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 organization ahead of ourselves or our team