5 dagen geleden

Position Title

Manufacturing Science and Technology MSAT lead Cell culture

Geel (Belgium)

About the opportunity

Join Sanofi Belgium as Manufacturing Sciences & Technology (MSAT) Lead Cell Culture and provide leadership to a team responsible for technical oversight and support of manufacturing activities within the global biologics network.

Your team will consist of Manufacturing Science (manufacturing scale oriented) colleagues.

In this role you will lead Lifecycle Management of commercial processes, Commercial Manufacturing Support and Technology Transfer.

About the department

The drug substance function within global Manufacturing Science & Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within Sanofi biologics manufacturing network.

We deliver innovative, robust, and cost-effective next generation processes 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, synthorins and nanobodies.

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 MSAT Cell Culture team is located in Geel and is part of the Global MSAT organization, thereby supporting Geel based production processes / projects as well as projects within the broader Sanofi biologics network.

About growing with us

Starting from thorough scientific and technical knowledge, in this role you will

  • Provide technical leadership to a team ( 5 people) of scientists / engineers / PhDs with a solid background in large scale cell culture processes
  • Ensure realistic planning and prioritization of activities, keep oversight of delivering on commitments
  • Lead and coach the cell culture manufacturing science team guide and develop each member of the manufacturing science team both in execution of their responsibilities and in their own personal development.
  • Maintain a high-performance team that fosters accountability, open communication and continuous improvement / development

  • Identify process improvement opportunities to increase yield or process robustness, and generation of a supportive data package leading to implementation at manufacturing scale
  • 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 provide technical advice to questions of other departments
  • Use a solid understanding of scientific principles and professional practices to solve a range of complex deviations and issues in manufacturing in creative and practical ways
  • Lead / support technology transfer, initial process validation and process control strategy definition for introduction of new products and processes at manufacturing scale if applicable
  • Support regulatory filings and health authority inspections
  • Work closely together with the Process Sciences (small scale) team
  • Build a network and maintain good relationship with both internal (e.g. operations, quality, ) and external (suppliers, alliance partners, ) stakeholders
  • Maintain and demonstrate significant knowledge of the state-of-the-art technologies
  • Represent the Upstream team as an SME or technical lead in cross-site, cross-functional teams
  • About you

    Required Skills & Qualifications

  • PhD or master in Life Sciences, with relevant experience of minimum 5 or 7 years respectively
  • Proven experience in leading and developing high-quality, high-performance teams of scientists and engineers of diverse academic backgrounds and skill levels
  • Experience in mammalian cell culture processes on lab- and / or manufacturing scale; experience with purification processes is a plus
  • Familiar with current Good Manufacturing Practices & US / EU regulations
  • Familiar with various statistical and data trending techniques
  • Ability to drive change, innovation, team work and competitive performance as well as develop, inspire and motivate a team in the achievement of specific objectives
  • Flexible and willing to support both manufacturing scale operations and support small scale lab studies
  • Strong communicator, who is able to connect, go in discussion and find compromise with people in other departments or sites
  • Excellent analytical and problem-solving mindset, are accurate with the necessary eye for detail
  • Oral and written fluency in English
  • International mindset ability to work in a multi-site global organization and willing to travel (at least for short term) abroad
  • Terms of Employment

  • Function in day shift (flexible working hour system), 40-hours / week
  • Proposed start date : ASAP
  • We recommend that you inform your manager if you are interested in this position.
  • Candidates can add a resume and motivation letter to the vacancy in Workday.
  • 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.

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