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  • Location

    Leiden, Netherlands

  • Job title:

    Senior Scientist

  • Sector:

    Biotechnology

  • Job ref:

    43219

The company
The mission of this company is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for their health.

This team has a focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases. You will be a member of the Formulation Development team, which is part of the Drug Product Development department. 

Role description
You will be responsible for the late stage development of the Drug Product (formulation and primary packaging). Executing studies to evaluate the product during realistic conditions regarding transport, handling and use in the supply chain. Additionally you will perform studies to assess stability as well as compatibility with processes and packaging materials. You will closely collaborate with experts from process and analytical development, clinical operations and regulatory affairs. The outcome of the studies will be used to support process and distribution parameters in the whole supply chain. 

Responsibilities

  • Set-up, execute and report studies to deliver project objectives
  • Presenting the outcome internally and externally
  • Summarize the outcome of studies into regulatory documents and present to governance regulatory bodies
  • Advance the scientific understanding, set out of the formulation and filing strategy 
  • Investigate quality incidents from the end to end clinical supply 
  • Review scientific work and mentor other scientists

Requirements

  • Master or PhD in a relevant field 
  • Minimal 5 years' of industry experience in a biologics or vaccine development company
  • Experience in all facets of product development 
  • Working knowledge of assays, quality systems (GMP) and regulatory guidelines 
  • Team player with excellent communication, interpersonal and project management skills

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