Manuel Grund Roche Pharmaceuticals

Mr. Manuel Grund works for Roche's Pharmaceutical Division in the role of process engineer in Mannheim, Germany, holding a degree as state-certified chemical engineer. During his early professional years in the chemical industry, he accompanied pilot as well as large-scale manufacturing processes for the synthesis of organic and inorganic fluorine compounds for over a decade. With his move to Roche in 2016, Mr. Grund initially took a leadership role in the cGMP-regulated parenteral production of prefilled syringes. From 2018 to 2021, he supervised the aseptic drug product manufacturing of several biologics and small molecules in glass vials on a multi-purpose line for lyophilisates & liquids from a Manufacturing Science and Technology perspective. In addi-tion to root cause analyses and product quality impact assessments, his focus was on optimization projects relating to process robustness. He specialized in the areas of sterile filtration / filter integrity testing, glass fractography and cGMP auditing. Since 2021, Mr. Grund has been developing and validating preparation and tray filling processes in silicone-free COP primary packaging for parenteral launches. He is also responsible for the design conception and qualification of single-use systems. His ongoing studies in industrial pharmacy complement his profile.