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Novartis CH-S.A - A GSK Consumer Healthcare Company- Switzerland
- Technical Function Head
2013 - maintenant
Novartis CH-S.A - A GSK Consumer Healthcare Company- Nyon plant
Liquids and Semi-solids OTC products - ≈ 60 formulations - ≈ 700sku's (Nyon Plant Power brands Voltaren®- Otrivin®)
Lead of Technical function (MS&T -24 people): Integrated function within plant operations to support products and process
robustness.
Building and Development of MS&T organization in 2013 (Structure, Strategy , Processes) Capability build- People & Talent
development -Budget management (CHF 5M)
Membership of the Site Leadership Team and Global CH Technical community -Cross functional partnership: Quality- Engineering,
Operations, supply, regulatory, R&D, global Technical and Category.
Ownership of core technical business processes for Nyon plant:
-Product Lifecycle Management (PLM): Technical Risk Assessment, Process qualification (Process & cleaning validation), Product
Control Strategies, Continued Process Verification, change control & risk management. Responsible for PLM governance and
knowledge management of products through PLM.
-New Product Introduction(NPI) and Technical Transfer to other GMS sites/third party manufacturers
-Raw materials and packaging materials introduction, quality improvement , change control & risk management
Lead of key initiatives like Cost saving - De-risking -Compliance/remediation-transfer (in/out) projects
Support /lead trouble shutting, Root Cause Analysis (RCA),providing technical leadership of technical issues impacting Quality, supply.
Delivery of key process improvement /optimization contributing to COPQ, BRFT, CoG, waste, yield...
Support / Drive innovation in partnership with R&D, engineering, Global organization
Accountable for ensuring compliance to current European standards
Exposure to health authorities & internal inspections
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JOHNSON & JOHNSON R&D OTC Europe
- Associate Director R&D Product Development
New Brunswick
2010 - 2013
Lead of Formulation/ Industrial Development department: (12-15 people)- Solids, semi-solids, liquids formulation
Representative of R&D OTC Europe organization, member of R&D community at international level.
Budget, technical, people management & development. Organization design, Innovation process implementation and project management approach.
Lead of new products formulation in GMP environment from pre-formulation to scale up including, pilot, clinical batches
Support to marketed products ownership: Scale up, Production transfer, Reformulation, process improvement, raw materials, primary packaging changes, dual sourcing, cost improvement.
Cross-functional collaboration with Internal European partners (Marketing, Regulatory, clinical, Quality, Supply chain, Production) and external partners (Contractor, Production, suppliers).
Technology watch: Identification and development of new technologies. Technical feasibility studies, university partnership.
Innovation: Development of API taste masking new technologies (Oro-dispersible tablets, stick pack), innovative galenical form for sore throat.
Support to Regulatory, writing of relevant technical CTD dossier section, due diligence
Exposure to internal and Health authorities inspections & EHS inspections
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Johnson & Johnson R&D OTC Europe
- Directeur adjoint R&D Développement produit
2010 - 2013
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Industrial Development department
- Manager Project Development and Formulation
2006 - 2010
Lead of Formulation/ Industrial Development department: (12-15 people)- Solids, semi-solids, liquids formulation
Representative of R&D OTC Europe organization, member of R&D community at international level.
Budget, technical, people management & development. Organization design, Innovation process implementation and project
management approach.
Lead of new products formulation in GMP environment from pre-formulation to scale up including, pilot, clinical batches
Support to marketed products ownership: Scale up, Production transfer, Reformulation, process improvement, raw materials,
primary packaging changes, dual sourcing, cost improvement.
Cross-functional collaboration with Internal European partners (Marketing, Regulatory, clinical, Quality, Supply chain, Production)
and external partners (Contractor, Production, suppliers).
Technology watch: Identification and development of new technologies. Technical feasibility studies, university partnership.
Innovation: Development of API taste masking new technologies (Oro-dispersible tablets, stick pack), innovative galenical form for
sore throat.
Support to Regulatory, writing of relevant technical CTD dossier section, due diligence
Exposure to internal and Health authorities inspections & EHS inspections
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Johnson & Johnson R&D OTC EUROPE
- Formulation LaboratoryManager
2001 - 2005
Management of Formulation of new OTC products, lead of GMP lab including manufacturing, supply of investigational products
(GMP lab trial /pilot clinical Phase I-II-III), solid, semi-solid, liquid formulations.
-Team management (4- 6people): Human, technical resources and budget management.
-Support for designing new R&D center and labs ( Equipment, zoning, flow...) and implementation of lab quality system
-Project management: Internal /subcontracting.
-Development of innovative formulations sustained release tablets, quick dissolution tablets and various liquid formulation
-Manufacturing process validation at pilot scale, Technical support to scale up.
-Work in collaboration with marketing, clinical, regulatory, supply chain, quality at European and international level
-Management of manufacturing, supply, labeling, of clinical product in Europe and outside Europe.
-Laboratory continuous improvement, equipment management (Purchase, qualification, preventive maintenance, changes..).
-Maintenance of compliance to GMP and EHS standards, exposure to internal & health authorities inspections
JOHNSON &JOHNSON R&D OTC Europe (France 03)
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Johnson & Johnson R&D OTC EUROPE
- R&D Project Manager
2000 - 2000
Project coordination in collaboration with R&D, regulatory, marketing
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JOHNSON & JOHNSON R&D OTC Europe
- Dossier responsible
1999 - 1999
Dossier responsible - Nov -Dec 1999 : Writing of Module 3 CT D dossier
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JOHNSON & JOHNSON R&D OTC Europe
- Junior Project Manager
New Brunswick
1999 - 1999
Project coordination in collaboration with R&D, regulatory, marketing
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JOHNSON & JOHNSON R&D OTC Europe
- Junior Scale up Manager
New Brunswick
1999 - 1999
Management of scale up activities and marketed product changes
