Job title: Senior scientist, PAT
Senior PAT Scientist with the Digital Development and Analytics group at Biogen. Joined the company in 2017, supporting the startup of Biogen’s the new Next Generation Manufacturing facility at Solothurn Switzerland. Since 2015 working for Lonza at Visp, Switzerland, being responsible for the PAT laboratory. Delivered PAT solutions and consulting services to the global organization, including small molecule API manufacture and chemicals. Since 2009 several roles at Shell Global Solutions in Hamburg Germany around lubricants R&D. Managed the analytical services team, acted as global technical support manager, internal consultant, internal quality auditor and as project leader for R&D projects. Chemist by training with stops at the Universities of Braunschweig Germany, Salt Lake City Utah and Tuscaloosa Alabama. PhD in industrial chemistry sponsored by BASF SE with a focus on on-line NMR spectroscopy and reaction engineering of complex polycondensations.
Sensing Technology and Process Requirements 12:00 pm
• PAT in the product life cycle – how to connect process needs with technology • PAT technology readiness: what’s out there, what’s needed? • Data engineering for PAT • Compliance aspects – data integrity and GMP, monitoring vs. controllingRead more
day: Stream 2 - Day 2
Panel Discussion: Measure Vs Model in CM Validation & Approval 9:45 am
• What measurements can be replaced with a model, whilst retaining product quality and regulatory compliance? • How can regulatory approval for CM differ across the world? • Key differences between traditional bath processing vs continuous in regulatory submission, e.g. continuous process validation • Inspection preparedness as we move into commercial spaceRead more
day: Day Two