Senior Fellow - Pratteln, Schweiz - CK Science

    CK Science
    CK Science Pratteln, Schweiz

    vor 2 Wochen

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    Beschreibung

    Senior Fellow - Technical Development

    CK Group are recruiting for a Senior Fellow of Technical Development on behalf of a leading multinational pharmaceutical company. This role will be based at their site in Basel on an initial 12-month contract.

    The Role:

    You will be lead and driving formulation development and manufacturing activities for assigned projects, ensuring scientific and technological excellence focus on parenteral drug products.

    Responsibilities :

  • Collaborate closely with cross-functional teams to align formulation project plans with control strategies, project timelines, and overall development strategies.
  • Communicate and exchange knowledge with Biopharmaceutics Experts and internal subject matter experts to incorporate critical factors for absorption and DP-performance into formulation development strategy.
  • Generate accurate and comprehensive scientific documentation, including development reports and manufacturing instructions, to support development trials, process transfers, and supply activities.
  • Ensure compliance with regulatory requirements and support inspections by contributing to filing dossiers, addressing DP-related questions, and representing project/product-related aspects during internal and health authority inspections.

    • Your Background:

  • Advanced degree in scientific or relevant discipline (Masters or equivalent)
  • Desirable: Ph.D. in scientific or relevant discipline or equivalent.
  • Previous experience (minimum 3 years) in the development of sterile pharmaceutical formulations.
  • Strong knowledge of relevant GxP regulations and policies related with aseptic/sterile manufacturing.