Expert II, MSAT Material, EVF

Purpose

Sanofi Manufacturing and Supply Organization is preparing its future through an ambitious program named EVolutive Facility (EVF). The EVF 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 EVF 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 EVF Singapore is seeking a MSAT Material Expert to refine and execute strategies of single use systems and raw materials during project startup, process validation as well as routine manufacturing. The Material Expert will be accountable for material design, qualification strategy and plans from a site process technical expert perspective, to ensure process materials and their cGMP documents are timely and of adequate process and compliance quality. The Material Expert is self-directed in representing MSAT in the site Material Council while managing internal stakeholder expectations and communications. 

Duties & responsibilities

Single use systems (SUS) & raw materials (RM) in bioprocess designs
•    Key member of site material council. 
•    Select and design raw materials and Single use systems for site- and molecule-specific usages in both upstream and downstream processes, in consideration with global standardization strategies and fit to EVF vision.  
•    Build and promote systems and tools for (i) standardization concepts and implementation, (ii) sharing and retention of design knowledge, within site and Sanofi network. Consolidates strategies through

Strategic Plan, Guidance or appropriate tool/deliverable.
•    Author MSAT technical documents relating to material sciences including extractable and leachable assessments while ensuring regulatory compliance. 
•    Lead site-level projects involving key process material changes. May lead network-level projects.
•    Is (or work towards) a site Single use systems expert, or network key opinion leader.

Single Use Systems & Raw Material qualification & control

•    With support from MSAT Senior Manager during the transition phase, make MSAT decisions relating to development and execution of process design, material onboarding, and documentation readiness, in both upstream and downstream processes.
•    Execute raw materials & Single use systems 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, independently lead material-related investigations from a scientific perspective. May be part of after-hours MSAT on-call system to support manufacturing disruptions.

Single Use Systems & Raw Material in molecule lifecycle management 

•    With support from MSAT Drug Substance Leads & Process Engineers for nuances on bioprocess and molecule, make MSAT decisions on and execution leading to material readiness for both upstream and downstream processes.
•    Provide MSAT technical perspective and main author for 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 leading/supporting Life Cycle Management initiatives including CoGS reduction, supply continuity plans. 

Pre-requisities

Knowledge, Skills & Competencies / Language

•    An effective communicator and productive in multi-functional & multi-cultural communication settings. 
•    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 broad industrial experience in biopharmaceutical projects including RM and Single use systems design, sourcing and qualification.
•    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