Senior Scientist - Immunomonitoring (m/f/d)

Your Profile:

• Post-graduate (PhD) academic education in the bio/life sciences
  
• At least 5 years' experience in vaccine development/immunology/infectious diseases, preferably in industry
  
• Experience in development, optimization, qualification and/or validation of immunological assays compliant to international guidelines
  
• Experience in clinical sample testing using immunological assays (ELISA, ELISpot, cell-based assays, flow cytometry, multiplex technologies) and designing assays with automated systems
  
• Experienced in working with external partners, i.e. CROs
  
• GCLP knowledge
  
• Highly self-motivated, organized and able to work independently as well as collaboratively in a team with excellent organizational skills and critical-thinking skills
  
• Excellent written and spoken english skills

Your Tasks:

• Daily management of vaccine immunogenicity testing using clinical trial samples, including assay monitoring, troubleshooting and CRO oversight of offsite sample storage and shipments
  
• Method development, optimization and validation as required, in compliance with international guidelines
  
• Responsible for automating plate-based assays utilizing liquid handlers (e.g. Biomek i7)
  
• Maintain and improve GCLP quality standards, including preparation and review of technical and quality documents (SOPs, protocols, reports, change requests, deviation reports) and planning, executing and reporting equipment and software qualifications
  
• Data analysis and interpretation of results. Present and discuss results of experiments with the department and project teams.
  
• Collaboration with QA, regulatory and clinical department and internal cross-functional teams
  
• Train, mentor and supervise technicians and research associates

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