Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. 

This job offer is accessible to all, regardless of gender. 

Job title: Senior Scientist, DSP Process Engineer - Tech Transfer and Production Support

• Location: Vitry-Sur-Seine
• Remote Work: 40% remote working and 10% travel expected
• Job Type: Permanent

About the job

As Senior Scientist, DSP Process Engineer within our BioProcess Engineering (BPE) team, you'll lead technical transfer activities and provide critical production support for biologics manufacturing across our global network. Ready to get started?

The BioProcess Engineering (BPE) team, part of the Mammalian Platform unit of the Global CMC Development organization, is responsible for the execution of pilot-scale batch manufacturing and technical transfers for all levels of clinical development. For early-phase clinical material production, BPE acts as receiving site coordinator on behalf of our manufacturing facilities. For late-stage clinical, early-stage commercial, and external clinical material production, BPE acts as the sending site coordinator and works closely with process owners, sourcing partners, and the Manufacturing & Supply organization.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities:

• Lead technical transfer activities including facility-fit assessment and operational readiness assessment and provide technical support as SME (Subject Matter Expert) for processes (mainly DownStream Process)
• Support GMP manufacturing operations and act as Drug Substance lead for programs from Cycle 1 to Cycle 3 when necessary
• Partner with all relevant functions from R&D and Manufacturing & Supply to perform facility fit assessment, GMP operational readiness assessment, and authorize transfer documents
• Act as a data steward by gathering and compiling process data for projects with support from Development, GMP manufacturing, and Analytics teams for development runs, scale-up batches, and GMP batches
• Create data visualizations for reviews, assessments, and process anomaly root cause analysis
• Lead evaluation and implementation of new process platforms and manufacturing technologies
• Write and revise protocols, procedures, reports and other process-related documentation to support process scale-up, transfer, and implementation to cGMP manufacturing operations

About you

Skills that you have (mandatory):

• Engineering Degree in Chemical Engineering, Biochemistry, Biotechnology, or related field with industrial experience in manufacturing or process development of biologics
• Experience in leading matrix teams
• Excellent oral and written communication skills to build relationships both inside and outside the company
• Experience working on multiple complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities
• Fluent in English, French speaking in writing, reading and presenting

Skills that you could improve in this new position (to develop):

• Experience in manufacturing or process development of biologics, preferably produced in recombinant protein purification systems, with knowledge on scale-up, process transfer, and cGMP manufacturing operation
• Working knowledge in recombinant protein GMP quality standards and regulatory requirements
• Experience in defining process control strategy and process validation and performing risk assessment following the QbD principle
• Experience in Data Analysis using existing tools and willingness to develop/evaluate new ones in the context of the global Digitalization strategy

Skills that you could offer in addition (nice to have):

• Ability to gown and work in manufacturing areas
• Ability to work flexible hours
• End-to-end biologics process knowledge, including cell culture and formulation knowledge

Why choose us?

• Shape the future of medicine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply
• Power