Senior Director Analytical Excellence (m/f/d)

Your Profile:

• An advanced degree in natural sciences (pharmacy, chemistry, biotechnology, biology or equivalent)
  
• Profound professional experience in the analytical development of pharmaceuticals covering different modalities and throughout preclinical and clinical stages
  
• Proven knowledge in analytical method development, validation, and related robust studies applied during pharmaceutical product lifecycle
  
• Strong team leadership experience, typically gained through at least 10 years of experience with line management responsibilities and in matrix organizations
  
• Broad knowledge of analytical methods and technologies for biologics. Experiences with different modalities as DNA, RNA, peptides and antibodies are a plus
  
• Solid know-how of regulatory requirements for pharmaceutical development

Your Tasks:

• To ensure that analytical method target profiles are set-up fit for intended purpose and method development is phase appropriate
  
• To propose, develop, and establish tools for method development and robustness studies which can be applied for different technologies and leverage from prior knowledge of the analytical platform
  
• To guide teams by development and troubleshooting of analytical methods by applying state-of-art tools and systematic approaches
  
• To support teams on hand-over of analytical methods to other functions (QC) and other sites
  
• To identify critical issues related to method performance and robustness and proactively implement activities for their resolution
  
• Representation of the analytical development organization in governance and review meetings to share guidance or as analytical SME
  
• Development of internal guidelines to ensure harmonized analytical method development across programs and technologies and enabling analytical teams by training

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