Thomas Block

About

„I am a creative out-of-the-box thinking person with strong operating experience in project work, quality operations and self organization. I am determined, humorous, conscientious and convincing.“ I have a Master Degree in Medical and Pharmaceutical Biotechnology

Experience

• MSD (9 yrs 7 mos)
  • MPS and Projects Lead
    Jan 2024 - Present · 2 yrs 6 mos

    Entwicklung von Kennzahlen (KPI) Effizienz Analyse der Produktionsanlage (OA/OEE/ Changeover) Standardisierung und Optimierung Prozess Kapzitätsanalyse Identifizierung von notwendigen Projekten zur Kapazität Steigerung sowie notwendige Optimierung von Prozessen Ausarbeitung und Lenkung eines Großprojekts bis 2028 zur Kapazitätsteigerung Einführung CCIT (Container closure integrity Test) Team Führung

  • Process Specialist Aseptic & Compliance
    Oct 2021 - Jan 2024 · 2 yrs 4 mos

    Entwicklung und Umsetzung von Strategien zur Medien Simulation (APS) in der Steril Abfüllung und Bulk Produktion (Routine + initiale Simulation im Zuge Übergang Projekt in Routine des neuen Standorts( Annex 1 GAP Analyse und Einführung der Contamination control strategy (CCS) für den Standort Problem solving bei komplexen Abweichungen (8-Step bzw A3 Methode)

  • Process Expert Logistik
    Mar 2018 - Oct 2021 · 3 yrs 8 mos

    Projekt Engineering Set up of new facility Logistics expert Lean Design Quality by Design (QbD) Cleanroom design Change Management Cost Management URS

• Quality Specialist at Baxalta
  Sep 2012 - Jun 2016 · 3 yrs 10 mos

   Quality core team member with full responsibility for Regulatory and GMP Questions during Project (New production site in Krems an der Donau)  Establishment of electronic Batch Record System with global harmonization  Setting up new SOP structure  Deviation and CAPA Management  Batch record control and GMP inspections  Audit Support

• Scientist at IMC FH Krems
  Jan 2011 - Feb 2012 · 1 yr 2 mos

   Assay development in Phage display Technology - TNFa  Production / isolation of proteins and system optimization  Assay development in cell-culture based systems  Installation of FPLC system and programming methods for protein purification from crude extracts

• Scientist at Sealife Pharma GmbH
  Dec 2009 - Aug 2010 · 9 mos

   Isolation / Screening of marine extracts towards anti-infective activity  Toxicity and MIC tests  Installation of semi preparative HPLC system and development of methods for protein purification from crude extracts with unknown target properties