LILLE
RETROUVEZ GRATUITEMENTLe résultat des européennes à Lille ainsi que le résultat des européennes dans le Nord.
Working for more than 15 years with various positions in small biotech and big pharma companies (Vivet-Therapeutics, Ablynx, UCB Pharma), I am a CMC expert with track records spanning NCEs, NBEs and GT projects transitioning from research through pre-clinical development and clinical PoC up to commercial launch (e.g. Brivaracetam/Briviact®, Caplacizumab/Cablivi™)
MAIN EXPERTISE AND RECORDS
PROCESS DESIGN (PROCESS VALIDATION STAGE 1):
- Manufacturing process development and scale-up for multiple products (NCEs, NBEs and GTs)
- Definiton and identification of products' QTTP, CQAs and process characterization (categorization and criticality assessment of the process control elements)
- Design and implementation of the overall approach and specific templates at Ablynx (incl. SOPs)
PROCESS QUALIFICATION (PROCESS VALIDATION STAGE 2):
- Led the commercial DS&DP processes performance qualification (PPQ campaign) of Caplacizumab
- Implementation of the process validation SOPs
- Definition of the process control strategy (PCS)
- Development and justification of the DS and DP release specifications
PRODUCT LIFECYCLE, ONGOING/CONTINUED PROCESS VERIFICATION (PROCESS VALIDATION STAGE 3):
- Implemented the ongoing/continued process verification procedure incl. specific templates at Ablynx
- drafted the stage 3 program protocol for Caplacizumab
CMC PROGRAM MANAGEMENT AND LEAD:
- Led several CMC programs from early to late development stages including MAA/BLA
- Short/middle and long-term planning and budgeting (incl. ressources assessment)
- Managed multidisciplinary and cross functional teams (RA, QC, QA, CMC development and supply)
REGULATORY:
- Fluency in CMC regulatory requirements (ICH/FDA/EMA guidances)
- Writer/reviewer of quality sections of regulatory dossiers (e.g. Module 3 of MAA, IND/IMPD, Type C and SAWP briefing packages): 1st MAA submission of Caplacizumab with no major objections on Module 3
Mes compétences :
Chef de projet
Chemical Process
Chemistry
Chimie
Chimie organique
Chromatography
CMC
CRO
Industrial process
Management
Management d'équipes
Management de projet
MCC
Outsourcing
Procédés industriels
Process
Process Development
Recherche
Recherche et Développement
Research
SMB
Transfert de technologie
Validation
Validation de procédés
