Director Analytical Development (m/f/d)

What is important to us:

• Scientific degree in life sciences with a focus on analytical techniques for proteins and more than 5 years of experience in analytical development in the biopharmaceutical industry
  
• Strong leadership skills and experience with the leadership of large organizational units
  
• You are a team player and enjoy working in multidisciplinary teams irrespective from hierarchic levels
  
• Strong background in method development, validation and regulatory guidelines for protein drug substances (CE, HPLC, ELISA, Bioassay)
  
• Sound understanding of protein chemistry and associated CQAs
  
• Experience in the management of organizations working on a variety of products is a plus

Tasks and responsibilities:

As Director Analytical Development (m/f/d) you will be responsible for different teams and laboratory units reporting to the Quality Control department. You will lead and support analytical activities and strategies related to method development, -validation and comparability assessments for multiple early- and late-stage programs for our customers.

• Lead and mentor internal and external teams throughout the analytical lifecycle (method development and validation) of drug substance, drug product and intermediates
  
• Define and oversee science-driven, phase-appropriate analytical development and validation strategies and related business processes for internal and external labs that are consistent with cGMP and international guidelines
  
• Work with multidisciplinary teams and collaborate with other areas in process development, manufacturing, as well as external parties
  
• Deliver analytical solutions that enable process -, product - and analytical control strategy development
  
• Support the definition of critical quality attributes and establish robust analytical control strategies that can be transferred into Quality Control and successfully registered globally
  
• Develop and manage method development and validation metrics for performance improvement of the team
  
• Represent Analytical Development and Quality Control to internal and external customers
  
• Provide leadership to aid in analytical investigations and assay trouble shooting
  
• Review and approve analytical documents including but not limited to protocols, reports and procedures
  
• Review analytical sections in regulatory submission documents (e.g. IND, IMPD, MAA, BLA)
  
• Identify and monitor disruptive analytical technologies and regulatory trends

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