Head Operations Bioanalytics (m/f/d)

Minimum requirements:

• PhD in Natural/Biological Sciences with 10 years + practical experience in bioanalytics and immunology
  
• Experience in people and operational management
  
• Experience in bioanalytical assay development and validation (PK/PD and immunogenicity)
  
• Experience with regulatory agencies/guidelines and industry standards
  
• Good understanding of GxP, ISO17025
  
• Excellent interpersonal, leadership and teamwork skills
  
• German and English fluent in written and spoken

Your key responsibilities:

• Management and supervision of the bioanalytical operational activities at the site Oberhaching with 5 laboratory teams
  
• Ensure timely development and validation of bioanalytical PK, PD and immunogenicity assays as well as analysis of serum samples for the support of preclinical and clinical trials
  
• Represent Clinical Bioanalytics for assigned project internally and externally and provide scientific expertise to the bioanalytical testing as well as strategic planning activities.
  
• Plan laboratory operation resources according to project priorities
  
• Ensure timely preparation of SOPs, analytical plans and reports according to GxP/ISO17025
  
• Support and drive bioanalytical laboratory excellence projects
  
• Support preparation of scientific documents including registration documents and lead interaction and communication with HA.
  
• Ensure compliance with legal (e.g. radiation safety, biological safety, worker safety) and regulatory requirements (GxP, ISO17025)
  
• Professional development of associates.
  
• Budget planning

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