Quality Control and Analytical Development

What you  will get…

• > 10 years of experience in biopharmaceutical QC and analytical development (mABs, bi-specific mABs and other proteins, Nucleic acids)
• Extensive knowledge of QC release and stability testing using various biochemical and microbiological assays 
• Setting of specifications
• Method development, Method qualification and validation, Method transfer

• Experience in qualification of product reference standards
• Participation in CMC projects as QC team member throughout the product life cycle in contract manufacturing and for company own products/development products
• Knowledge of international guidelines, Establishment of QC procedures (OOS,OOT etc.)
  
• Support in preparation of filing documents throughout the whole product life cycle starting (Clinical Phase I-III,  PAI and launch, commercial phase)
• "Leiter der Qualitätskontrolle" according to German Pharmaceutical Law