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Job title: Expert II, Manufacturing Science and Analytical Technology (MSAT), Material, EVF

• Location: Singapore

• Hiring Manager: Head of Manufacturing Technology, EVF

About the job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi has added two new Evolutive Facilities to our global industrial footprint. These production units (EVF) represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people’s lives by giving them faster access to more treatments.

Main 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.

About You:

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

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)