MSAT Drug Substance Lead

Job title: MSAT Drug Substance Lead

Location: Singapore

Hiring Manager: Head of Manufacturing Technology

About the job:

Mission

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 sites 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 Drug Substance Lead to provide technical expertise for both upstream and downstream biological process areas in various activities like new product introduction, process transfer & validation, shopfloor support and lead process investigations. The MSAT Drug Substance Lead is expected to lead complex and/or multi-step deviations & CAPA plans, and can be consulted by Engineering & Manufacturing leads for complex process equipment & operational workflows, and/or those with high interdependency. This role also provides coaching to junior members of MSAT, and is expected to specialize to become a network Subject Matter Expert/ Key Opinion Leader. 

Key accountabilities

Process design & engineering:

• Support to build transverse Modulus process & process engineering strategies for consistency across products & platforms.
• Support core process (cell culture to bulk drug substance) equipment activities in capital projects from business case to commissioning & qualification.

Process transfer & validation:

• Own, project manage & successfully execute the process transfer of new molecules (upstream and downstream), including defining manufacturing processes, establishing strategies behind process validation and process control. This is to be established by working closely with cross-functional representatives in sending and receiving units. Leverage on Modulus MSAT engineers in a matrix structure. 
• Upstream and downstream SME to provide scientific/technical expertise including process equipment, process mass balances, process validation and process design & control. 
• Author strategic and/or complex MSAT technical documents (e.g. plans, control strategies, memos, protocols, reports) during process transfer & validation phase and process monitoring. Supports regulatory filing. 
• 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 is main author for MSAT documentation in strategic and/or complex 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:

• Primary site contact for appointed products, with strong connection and alignment with global technical product teams.
• 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 a domain expert at site, or network key opinion leader.
• Mentors junior MSAT coworkers.

About You

Pre-requisites

Knowledge, Skills & Competencies, Language:

• Strong leader with strategic vision, scientific know-how and operational mindset.
• 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 successful broad industrial experience in mammalian biopharmaceutical projects, particularly in process engineering, 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.