DSP Process Expert - 12 mois.

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  • categoria
    industria
  • Contatto
    Estelle Kotelon
  • riferimento
    129085-40305

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dettagli di lavoro

The Manufacturing Excellence department integrates cell banking, scale-up tech transfer, and GMP manufacturing expertise to facilitate rapid product development. Its mission is to transform development processes into highly automated manufacturing systems that ensure the delivery of safe and effective drugs to patients. The DSP Process Expert oversees the manufacturing strategy and compliance at large scale for all pipeline programs, while also enabling the implementation of new technologies.

You will be responsible for:

  • Establish Large Scale Manufacturing strategy aligned with NBE/ADC program mandates.
  • Plan Large Scale Technology Transfer activities in accordance with the NBE development program.
  • Coordinate the preparation and maintenance of necessary procedures and reports for technology transfer and manufacturing activities.
  • Provide technical expertise for decision-making during manufacturing issues and ensure data collection and analysis from large-scale runs.
  • Initiate and coordinate sample exports and codification processes in collaboration with GDSD ME and Supply departments.
  • Offer process expertise for raw material changes and large-scale process assessments related to new equipment transfers and qualifications.
  • Ensure compliance with Technology Transfer activities and contribute to deviations, CAPA definitions, and operational excellence initiatives.

The Manufacturing Excellence department integrates cell banking, scale-up tech transfer, and GMP manufacturing expertise to facilitate rapid product development. Its mission is to transform development processes into highly automated manufacturing systems that ensure the delivery of safe and effective drugs to patients. The DSP Process Expert oversees the manufacturing strategy and compliance at large scale for all pipeline programs, while also enabling the implementation of new technologies.

You will be responsible for:

  • Establish Large Scale Manufacturing strategy aligned with NBE/ADC program mandates.
  • Plan Large Scale Technology Transfer activities in accordance with the NBE development program.
  • Coordinate the preparation and maintenance of necessary procedures and reports for technology transfer and manufacturing activities.
  • Provide technical expertise for decision-making during manufacturing issues and ensure data collection and analysis from large-scale runs.
  • Initiate and coordinate sample exports and codification processes in collaboration with GDSD ME and Supply departments.
  • Offer process expertise for raw material changes and large-scale process assessments related to new equipment transfers and qualifications.
  • Ensure compliance with Technology Transfer activities and contribute to deviations, CAPA definitions, and operational excellence initiatives.

  • qualifiche

    • Education: Master's degree of Science or Engineering.
    • Experience: At least 5 years of industry experience.
    • Quality Assurance: Designs and conducts quality checks for reliable processes.
    • Technology Application: Optimizes products/services using new technologies.
    • Project Management: Ensures timely delivery of results according to project plans.
    • Languages: Proficient in English; intermediate in French.

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EK

Estelle Kotelon

  • Randstad Merck Aubonne

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