Dr. Florian Grundmann, F. Hoffmann-La Roche AG, CH - Qepler Summits And Conferences

Dr. Florian Grundmann

MSAT Team Leader Cleaning Validation
F. Hoffmann-La Roche AG, CH
Basel, Switzerland
Grüetzi and welcome to Roche in Switzerland. Get to know us.

Dr. Florian Grundmann is currently Group Lead Cleaning Validation, Manufacturing Science and Technology at the Roche Kaiseraugst Sterile Production.

Dr. Grundmann studied Pharmacy and earned his Ph.D in molecular biotechnology from Frankfurt University in Germany und subsequently fulfilled several functions with increasing responsibility in pharma manufacturing.

He started in the production department of Novartis Pharma Stein AG where he obtained his Lean Six Sigma Green Belt with the technical stabilization of a prototype capsule filler (MG2 Multiflexa) for new inhalation drugs.

At Roche in Basel he continued in small molecules drug product Manufacturing Science and Technology with focus on transfers, cleaning validation, cleaning process development and the implementation of continued process verification. After a global assignment where he was responsible, to improve DMS and CAPA performance at the Roche small molecules manufacturing network he worked in the biologics drug substance quality department responsible for the quality oversight for validations.

In his latest position as Group Lead Cleaning Validation for steriles manufacturing (biologics and small molecules drug product) he and his team are responsible for cleaning validation oversight & execution from conception to implementation to realization to documentation to life cycle management as well as ensuring compliance to cGMP, PQS and Health authority requirements.

Related Sessions:

2nd Annual Highly Potent APIs
Summit 2020

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.
  • 19 Feb 2020
  • Prague, CZ
  • Pharma
Day 2: Thursday, 20 February 2020
CASE STUDY: Challenges of introducing an ADC into a multi-purpose Drug Product facility.
  • Cross Contamination Control Concept
  • Cleaning Validation and Monitoring Strategy
  • Deriving most stringent Acceptance criteria
  • Challenges in production routine
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