Management & leadership
• Operational excellence, Role & Responsabilities, New processess
• Transition, Change & Crisis management
• Due diligences & expertise
Stallergenes Greer
- Senior Director, Analytical Development
ANTONY2014 - 2017(Immunotherapy medicinal products targeting allergy: 1,400 FTEs, 2014 TO € 280M)
Senior Director, Analytical Development
Analytical development
• Designed and headed the implementation of strategies for the development of active Drug Substances and Products
• Developed/validated/transfered compendial or non-compendial methods in Immunology,Chemistry & Microbiology
• Fostered innovation and upgraded technical resources
• Oversaw lab activities: GMP compliance, Quality Events (CAPA, OOS, OOT), IQ/OQ/PQ qualification, critical reagents
• Compliance with all relevant French and foreign referentials (ICH/EMA/FDA guidelines & USP/EP/JP Pharmacopoeiae) and SME/process owner during ANSM/FDA/PMDA inspections
• CMC team leader for House Dust Mites tablets
Management & leadership
• Lead a department of 54: 4 group leaders, 13 team leaders, 37 technicians: recruitment, training, coaching, resource allocation.
• Managed financial resources (€1-2M OPEX, €0.5-1M CAPEX, personal costs, ROI), budgets, contracts and quality agreements.
• Change management: reorganized and integrated 2 teams, setup new processes for Specifications and LCM,
• Coached collaborators for project management and transversal teams.
Texcell
- Co-founder & VP, ImmunoProfiling
Évry2003 - 2014(Services in Biosafety and Bioanalysis for biological pharmaceuticals products
From 15 FTEs/one site to 60 FTEs/two sites in France and in the USA)
Corporate / Finance
• Cofounder and Member of the Board (2007-2013) of TEXCELL and SOPARBIOTECH (holding)
• Business plans, Road-shows, forecasts, P&L
Creation and management of a new Business Unit: ImmunoProfiling (Turnover: 900k€, 7-10 FTE)
• Coordinated Lab installations, planning, budget, IQ/OQ/PQ qualification, 21 CFR 11
• Structured and managed the teams: recruitment, training, coaching, resource allocation
• IP, CDAs, supervised contracting and lead negotiations
• Managed subcontractors/CRO: in vivo studies & clinical sample logistics
• Supervised R&D, collaborations and grants (ANVAR, OSEO, PM’UP, EU FP7): 900k€
• Implemented Scientific and Regulatory watch (ICH/EMA/FDA/ANSM...)
• Implemented Sage X3 ERP and Agilent Electronic Laboratory Notebook software
Business Development for ImmunoProfiling BU (2011-2014)
• Sourcing / key accounts management, flyers, RFP/RFI
• Co-created TEXCELL’s day on Cell & Gene Therapy (ATMP)
Université Paris 6 Pierre et Marie Curie
- Moniteur
