Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

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:Head of Upstream/Downstream and PrISM Vitry, MSAT Recombinant Mammalian DS Platform

• Location: Vitry, France

About the job

Sanofi’s Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization.

Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year.

The role provides leadership to the Vitry upstream/downstream MSAT team responsible for technical oversight and support of manufacturing activities at Vitry site within Sanofi global biologics network. In this role you will lead Commercial Manufacturing Support, Lifecycle Management (LCM) including process improvement of commercial processes, Scale up/Tech Transfer of commercial and late-stage clinical processes, Process Validation, and regulatory support. This role is crucial for maintaining efficient, compliant, and high-performing and eco-friendly manufacturing processes at the Vitry Site. The job holder is also the Primary Interface between Site & MSAT (PrISM) exercised through membership of the Site’s Leadership Team.

Main responsibilities:

• Provide technical leadership to the team of scientists and engineers with background in development and validation of cell culture upstream/purification downstream processes.
• Support and safeguard existing production processes by data trending and monitoring, generation of scientific/technical study protocols and reports including small scale lab study in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments.
• Collaborate across functions (upstream, downstream, analytical, CMC, manufacturing, regulatory) to deepen drug substance process knowledge, improving commercial manufacturing yield, robustness, and economics.
• Identify process improvements to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale.
• Lead technology transfer, process validation and process control strategy definition for introduction of new products and processes at manufacturing scale.
• Manage MSAT laboratories and use small scale models for studies conducted in lab environment to support commercial manufacturing investigation, LCM, and tech transfer.
• Support regulatory filings and inspections.
• Work with CMC process development teams within the Sanofi network to establish and implement platform approaches for activities and technologies applicable to manufacturing operations.
• Manage resource planning and prioritization of activities, oversight of delivering on commitments in respective areas within MSAT.
• Coach and develop the MSAT Team - mentor and develop each member of the MSAT team both in execution of their responsibilities and in their own personal development. Establish a high-performance team that fosters accountability, open communication, people development and continuous improvement.

PrISM (Primary Interface between Site and MSAT)

• Being an active core member of the Site Leadership Team, as the MSAT Functional leader, contributing to developing and execution of the Site’s roadmap in alignment with Manufacturing & Supply’s strategic plan and budget commitments.
• Responsible for local MSAT team cohesion, ensuring efficient communication and optimal service level between MSAT and the site leadership of Vitry and its stakeholders (including escalation of risks and issues, cascading of decisions and business updates…), through appropriate governance.
• Focal point of entry for understanding the  Site stakeholders' requests and engaging with the Global MSAT Network to ensure delivery; empowered to decide on behalf of MSAT.

About you

Qualifications/ Education & work experience

• Master or PhD degree in Biological/Biomedical, Sciences/Engineering
• 10 years of biopharmaceutical industry experience either in process development, process scale up, or process validation and manufacturing technical support
• Experience with large scale manufacturing support for mammalian cell culture processes, current Good Manufacturing Practices, US/EU regulations
• Experience with Tech Transfer and post approval life cycle management
• Proven experience in building, leading and developing high-quality, high-performance teams of scientists and engineers of diverse academic backgrounds and technical skill levels
• Ability to work in cross-functional and multi-site teams within a global matrix organization
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
• Ability to communicate effectively with internal and external stakeholders on status, needs, forecasts, risks and timelines
• Ability to drive change, innovation, teamwork and competitive performance as well as develop, inspire and motivate a team in the achievement of specific objectives
• Strong verbal and written communication and prevention skills
• Oral and written fluency in English

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.​​
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.​