Expert II, MSAT Material, EVF
Singapour, Singapour Permanent Date de publication 26/06/2024Purpose
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
Vous n'avez pas encore consulté aucune d'offres d'emploi
Vous n'avez pas encore enregistré d'offres d'emploi.
Évoluez
en tout point.
Repoussez vos limites. Développez votre carrière, votre réseau et apprenez quotidiennement auprès d’experts. Votre nouvelle équipe a besoin de votre énergie et de vos idées pour réaliser des avancées révolutionnaires.
En savoir plus
sur ce site
Un monde de possibilités
-
-
Quand vous évoluez, nous évoluons avec vous
Nous nous engageons à vous soutenir à travers une politique de rémunération complète, soigneusement élaborée pour contribuer à votre bien-être physique, financier, mental et social. Peu importe votre rôle, vous vous épanouirez au sein de nos équipes inclusives.
-
Construisez une carrière qui a du sens
Exprimez votre passion et impactez des millions de personnes à travers le monde. Vous êtes aux commandes : fixez vos objectifs et nous vous offrirons la formation et le soutien nécessaires pour les atteindre.
-
Lancez votre carrière
Explorez les possibilités : apprentissage, stages, postes pour jeunes diplômés, mobilité internationale. Vous serez accompagné pour avoir un impact significatif.
-
Nos sites
Nous sommes présents dans plus de 60 pays, tous unis pour définir l'avenir de la santé. Votre carrière évoluera aux côtés d'experts et grâce à la technologie au service des plus grandes avancées.
-
Histoires de Sanofiens
Rencontrez des membres de notre équipe. Ils utilisent leurs talents à la recherches des avancées qui améliorent la vie des gens. Quel que soit votre rôle, vous pouvez avoir un impact à travers votre carrière.
-
Pourquoi Sanofi ?
Accédez aux outils, à la formation et au soutien nécessaires pour atteindre vos objectifs. En réalisant votre plein potentiel, vous nous aiderez à atteindre notre objectif de réduire de moitié le temps entre la découverte et la thérapie.
-
Nos collaborateurs et notre culture
Audace, fierté et détermination sont les mots d'ordre. Des mesures concrètes sont prises pour que chaque Sanofien réussisse. La diversité est notre atout. Vous pouvez façonner notre avenir.
Que pourrions-nous accomplir ensemble ?
Rejoignez notre communauté mondiale des talents et contribuez à des projets qui changent des vies ! Chaque Sanofien s'engage dans des initiatives qui ont un impact réel sur le quotidien des gens.
Et vous, qu'aimeriez-vous accomplir ? Inscrivez-vous dès aujourd'hui et découvrez nos dernières offres dès leur publication !