Michael Dekner, Shire Austria GmbH now part of Takeda - Qepler Summits And Conferences

Michael Dekner

Head Fill & Finish Life Cycle Management support
Shire Austria GmbH now part of Takeda
Austria
Shire: The Leading Global Biotech Focused on Rare Diseases.

10/2017 – present: Head Fill&Finish Life Cycle Management support. Leading a team of senior manufacturing scientists responsible for process monitoring, technical product stewardship and process development, audit support, knowledge brokers, risk management (QbD) and linking to industrial and academic networks.

04/2015 – 10/2017: Shire (Baxalta), Innovation Manager, Lead Enhanced Process Control establishing innovation management process, communication, development of technology strategy and roadmap for real time release, technology scouting, linking to industrial and academic networks.

02/2014 - present: Lecturer for University of applied sciences Campus Wien, Downstream Processing - Lyophilization.

10/2011 – 04/2015: Baxter Bioscience AG, Supervisor Lyophilization and Crimping LA24B, aseptic processing, lyophilization, crimping, material flow, trouble shooting and maintenance, change management, NCR, leading 26 FTEs, coordination of an internal community of practice (Lyophilization), SME in projects on lyophilization and crimping, presenting at audits (FDA,…), continuous improvement.

06/2006 – 09/2011: f-star Biotechnologische Forschungs und Entwicklungs Ges.m.b.H; Scientist - screening, selection, expression and purification of binding antibody fragments, cell culture, protein engineering, immunology, analytics, microbial cultivation, cell sorting, molecular biology, fire safety, biological safety.

04/2006 - 05/2006: University of Natural Resources and Life Sciences, Vienna / Department of Biotechnology, Scientist - strain improvement

09/2004 - 03/2006: Biomin Gesunde Tierernährung International Ges.m.b.H, Scientist - enzyme production, fluidized bed coating, large scale cell cultivation, enzyme analytics, scientific support of master students

05/2004 - 05/2006: Lecturer for University of applied sciences Wiener Neustadt / Tulln, Biotechnology and Applied Microbiology

Related Sessions:

Pharmaceutical Lyophilization
Summit 2019

Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring and new products development.
  • 13 Feb 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 13 February 2019
BLOCK: MANUFACTURING & PROCESS DEVELOPMENT.
CASE STUDY: Ever tried. Ever failed. No matter. Try again. Fail again. Fail better! A (more) rational approach to lyo cycle development.
  • From trial and error to rational design
  • Experimental setup
  • Mathematical modelling of additional parameters
  • Lessons learned
View Details

2nd Annual Pharmaceutical
Lyophilization Summit 2020

Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring, new products development.
  • 12 Feb 2020
  • Berlin, DE
  • Pharma
Day 1: Wednesday, 12 February 2020
CASE STUDY: You don´t need to be great to start, but you need to start to be great – A pilot on multivariate monitoring for a lyophilized Product.
  • Multivariate monitoring for Fill and Finish
  • Challenges and roadblocks
  • Future plans
View Details