Ingénieur(e) Procédés Down Stream Process (H/F)

Job description

Sanofi Vitry-sur-Seine est l’un des sites les plus innovants du Groupe, avec plus de 2000 collaborateurs.

Doté d’un outil de production ultramoderne, le Biolaunch, le site maitrise à la fois les activités de recherche, de développement et de fabrication de biotechnologies.

Notre expertise ? Des produits visant à lutter contre le cancer et les maladies cardiovasculaires.

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.

Job Description:

As member of Manufacturing support, Transfer and Technology (MTT) group within Production department, which maintains manufacturing process knowledge and which ensures alignment of manufacturing operations with the registered process:

·  Provide expert technical support to commercial purification operations at Vitry-sur-Seine biologics site
·  Provide technical support to current good manufacturing practices (cGMP) operations in a multi-product cell culture and purification plant
·  Support the transfer and validation of new molecules
·  Partner with manufacturing and quality organizations in daily operations to maintain the process in reliable state of control
·  Develop process knowledge and ownership
·  Perform process monitoring using a variety of data analysis methods and techniques (e.g. excel, jmp, etc.)
·  Provide technical support and analysis for resolution of deviations, investigations and process issues
·  Identify, own and resolve process issues proactively
·  Lead proposal, initiation, testing and implementation of improvements changes to purifications processes (Process performance and production cycle time reduction)
·  Complete technical investigations and provide on-the-floor technical expertise
·  Generate documents (technical memos and reports, protocols, etc.) related to process monitoring programs and non-conformances
·  Participate in cross-functional initiatives

Basic Qualification:

·  Master’s Degree or PhD in engineering or science with 7 years of experience in cGMP manufacturing environment or biologics process development
·  Experience in mammalian cell culture purification techniques with in-depth understanding of large scale chromatography and UF/DF unit operations, principles of biochemical engineering, and process data analysis
·  Demonstrated ability to lead technical projects and small teams
·  Contributed to regulatory inspections and audit as Subject Matter Expert (SME)
·  Demonstrated commitment to continuous improvement

Preferred Qualifications:

·  Ability to make a significant contribution to cross-functional project teams through technical expertise and scientific creativity
·  Extensive experience in the process development, technical transfer, process characterization, and operation of large scale protein purification processes
·  Ability to work effectively in a highly collaborative and dynamic environment
·  Knowledge of purification technologies and operations
·  Knowledge of viral clearance of purification processes
·  Experience with automated protein purification chromatography and UF/DF
·  Experience with DeltaV Process Control system
·  An understanding of cGMPs and technology transfers
·  Familiar with analytical techniques (HPLC-SEC, SDS-PAGE, iCIEF)
·  The candidate should be self-motivated, strongly driven to succeed; inquisitive have excellent organizational, interpersonal, communication and problem-solving skills
·  Ability to team with internal and external collaborators to design, develop and implement key technologies downstream manufacturing processes
·  Prepare and deliver communication internally and externally to different audiences

Sanofi obtient la certification globale et France de Top Employer 2019

Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d'inclusion et créer un environnement de travail où ces différences peuvent s'épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous. Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.