• Proficiency in Quality Assurance aspects of biological drug development
  
  • Knowledge of GMP-based requirements
  • Training of R&D teams in QA aspects, follow up on daily documentation and work performance
  • Design and establishment of a Controlled Documents Bank
  • Support writing of SOPs, working instructions, protocols etc for all experimental work; design of forms for experiment documentation
  • Design of qualification and validation of assays in collaboration with R&D team, support performance and report writing
  • Definition of QA requirements for equipment, follow up on calibration and  maintenance
  • Good insights into Quality Control requirements for Biologics
• Good understanding in Protein Biochemistry
  
  • Protein expression in different expression systems
  • Protein purification – SEC, Inversed Phase, affinity (Akta)
  • Protein analysis: ELISA, WB, impurities (HPLC)
  • Chemical analysis
  • Protein activity analysis: In vitro and cell-based assays

Education and professional experience

• Ph.D. or M.Sc in Biochemistry/Chemistry from a certified academic institution
• At least 4 years’ experience in an industrial setting, preferentially Pharma or analytical laboratories
• Excellent English - native English level.
• Ability to work under pressure and in a constantly changing environment.