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

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