Leonardo Sibilio

Senior Process Consultant

Leonardo  has over 20 years experience in Process Development (Upstream & Downstream) of mAbs, recombinant proteins (from mammalian cells and E.coli) and adenoviral vectors.  Leonardo has held senior roles in a number of biopharmaceutical organisations including Menarini Biotech, IBI-Lorenzini S.p.A and ReiThera srl.  Leonardo holds a Master's Degree in Biology from University “La Sapienza” - Rome.

Skills include:

  • GMP Manufacturing: single use and stainless steel technologies up to 2,000 L bioreactor scale
  • Regulatory support: CMC for IMPDs and BLAs.
  • Process Development: USP and DSP expertise in Process optimisation and process characterisation, including QbD approaches.  
  • Process Validation:  Design of Process Performance Qualification and their execution.
  • Training: training in process development and process validation.
  • Leading and mentoring.
Leonardo Sibilio
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contactus@greyrigge.com