Jerome KELDENICH
Consultant at ARaymond
- Company
- PHARMA K CONSULTING SRL
- Position
- Consultant at ARaymond
- Biography
- Jerome Keldenich, PhD, is a CMC/MSAT leader and independent consultant, founder of Pharma K Consulting (Belgium). He specialises in aseptic processing and lyophilisation in GMP environments, with hands-on expertise aligned with EU GMP Annex 1 expectations. Over nearly 20 years, he has led CMC programmes from development through scale-up, validation/C&Q, and global technology transfer to commercial manufacturing across Europe, the US and Japan, including HPAPI/cytotoxic operations. Jerome has held senior leadership roles in both pharma and CDMO/CMO organisations, managing multi-disciplinary, multi-site teams spanning process engineering, pharmaceutical and analytical development, regulatory interfaces and project management. His experience covers small molecules (drug substance and drug product), peptides, mAbs, ADC, and multiple dosage forms, including injectables, lyophilised products and pre-filled syringes.
Speaker on
“A new paradigm in lyophilization: the shift toward plastic press-fit closures enabling streamlined cycles and direct in-chamber capping
Educational
LYOPHILIZATION 4.0: SMARTER / FASTER / GREENER
05/27/2026
|
14:20 - 14:35
|
TPD Room
Lyophilisation 4.0 | Smarter, faster, greener
Panel Discussion
LYOPHILIZATION 4.0: SMARTER / FASTER / GREENER
05/27/2026
|
14:35 - 14:50
|
TPD Room
