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Head of Upstream, MSAT Recombinant Mammalian DS Platform

  • Sanofi
Geel, Belgium
Full-time
Published:
  • Sanofi
Geel, Belgium
Full-time
Published:

ABOUT THE JOB:

Join Sanofi Belgium in our Manufacturing & Supply site in Geel as the Head of Upstream, MSAT (Manufacturing Science, Analytics, & Technology) Recombinant Mammalian DS (Drug Substance) Platform. In this role you will provide leadership to a team responsible for technical oversight and support of manufacturing activities within Sanofi global biologics network. Moreover, 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.

ABOUT OUR TEAM:

The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture based DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products.

Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion protein, antibody-drug conjugate. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.

The Geel MSAT Upstream team is part of the Global MSAT Recombinant Mammalian DS Platform organization, thereby supporting Geel based projects as well as projects within the broader Sanofi biologics network.

MAIN RSPONSIBILITIES:

  • Provide technical leadership to the team of scientists and engineers with background in development and validation of cell culture upstream processes;

  • Support and safeguard existing production processes by data trending and monitoring, generation of scientific/technical study protocols and reports in support of significant changes, product impact assessments upon significant deviations in the production process and provided technical advice to questions of other departments;

  • Work collaboratively with downstream, analytical, CMC project management, CMC regulatory and manufacturing to develop an increased depth of knowledge for the drug substance process for a given product and focus on improving the robustness and economics of commercial manufacturing processes;

  • 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;

  • Develop second-generation processes for existing commercial products using small scale models for studies conducted in lab environment;

  • Support regulatory filings and inspections;

  • Work with CMC process development team to establish and implement platform approaches for activities and technologies applicable to upstream operations;

  • Manage resource planning and prioritization of activities, oversight of delivering on commitments in respective area;

  • 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.


ABOUT YOU: 

  • Master or PhD degree in Biological/Biomedical, Sciences/Engineering;

  • Seasoned experience in biopharmaceutical industry experience in process development, process scale up/manufacturing and process validation;

  • 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 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, Dutch language will be a plus.

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