Experience

NH TherAguix

• France
• Research Services
• 1 - 100 Employee

• Director CMC

  • Nov 2020 - Present

  Meylan, Auvergne-Rhône-Alpes, France Implementation of CMC strategy for development of the lead drug candidate (AGuIX), a nanoparticle with theranostic properties, until commercialization. Supervise and manage activities at the selected APIs CMOs, vial Fill & Finish CMO, labeling / packaging / distribution CMO. Supervise and manage development and validation of analytical methods for release and stability testing. Selection of subcontracting back-up API CMO, back-up vial Fill & Finish CMO. Managing the CMC unit.



MILLENDO THERAPEUTICS

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Director CMC

  • Aug 2019 - Jun 2020

  Lyon, Auvergne-Rhone-Alpes, France Supervise and manage activities at the selected API CMO, vial Fill & Finish CMO, labeling / packaging / distribution CMO, and cartridge formulation development CMO. Review of reports relative to manufacturing process validation (Critical Process Parameters, Process Performance Qualification Protocol and Validation Master Plan) Manufacturing and release of API and Drug Product validation batches. Selection of subcontracting back-up API CMO, back-up vial Fill & Finish CMO, pen vendors… Show more Supervise and manage activities at the selected API CMO, vial Fill & Finish CMO, labeling / packaging / distribution CMO, and cartridge formulation development CMO. Review of reports relative to manufacturing process validation (Critical Process Parameters, Process Performance Qualification Protocol and Validation Master Plan) Manufacturing and release of API and Drug Product validation batches. Selection of subcontracting back-up API CMO, back-up vial Fill & Finish CMO, pen vendors, and cartridge Fill & Finish CMOs. Technical and quality audits for CMOs. Preparation and review of CMC regulatory documents (preNDA meeting Briefing document, NDA module 3). Supervise development and validation of analytical methods for release and stability testing. Supervision of a CMC Manager localized in US.

• Director CMC

  • Jan 2018 - Aug 2019

  Écully, Auvergne-Rhone-Alpes, France Implementation of CMC strategy for development of our lead peptide candidate (Livoletide) until commercialization. Selection of subcontracting labelling / packaging / distribution CMO. Preselection of subcontracting back-up API CMOs and back-up vial Fill & Finish CMOs. Supervise and manage activities at the selected API CMO, vial Fill & Finish CMO, and labeling / packaging / distribution CMO. Manufacturing and release of API and Drug Product registration batches. Preparation… Show more Implementation of CMC strategy for development of our lead peptide candidate (Livoletide) until commercialization. Selection of subcontracting labelling / packaging / distribution CMO. Preselection of subcontracting back-up API CMOs and back-up vial Fill & Finish CMOs. Supervise and manage activities at the selected API CMO, vial Fill & Finish CMO, and labeling / packaging / distribution CMO. Manufacturing and release of API and Drug Product registration batches. Preparation and review of CMC regulatory documents (IMPD, IND). Implementation of CMC strategy for development of livoletide pen. Leading livoletide formulation development to be used for pen cartridge. Supervise development and validation of analytical methods for release and stability testing.



Alizé Pharma

• Biopharmaceutical Development Manager

  • Mar 2009 - Dec 2017

  Écully, Auvergne-Rhone-Alpes, France Leading the bioprocess development, the analytical controls, the formulation development and any manufacturing activities related to new biopharmaceutical medicines (proteins, antibodies, peptides): full process from inception to final validation steps. Selection of subcontracting API CMO, Fill & Finish CMO, and analytical CROs. Technical and quality audits for CMOs and CROs. Key scientific contact within the company for CMOs and CROs. Key scientific person within the company for due… Show more Leading the bioprocess development, the analytical controls, the formulation development and any manufacturing activities related to new biopharmaceutical medicines (proteins, antibodies, peptides): full process from inception to final validation steps. Selection of subcontracting API CMO, Fill & Finish CMO, and analytical CROs. Technical and quality audits for CMOs and CROs. Key scientific contact within the company for CMOs and CROs. Key scientific person within the company for due diligence of external projects and due diligence from pharmaceutical companies (CMC and analytical parts). Initiation and management of the projects including drafting and implementation of development plans and Target Product Profiles. Preparation of the CMC and analytical sections of regulatory documents (investigators’ brochure, Briefing package, IMPD, IND). Review of regulatory documents (investigators’ brochure, Briefing package, IMPD, IND). Show less



Transgene

• France
• Biotechnology
• 100 - 200 Employee

• Head of Biochemistry Department

  • Sep 2006 - Mar 2009

  Région de Strasbourg, France Leading a team of 6 technicians, engineers and Ph D. Managing the biochemistry lab particularly expression purification and quality control. Reporting. Purchasing and maintenance of lab equipment in the laboratory (FPLC, HPLC, spectrophotometer, 2D gel apparatus, densitometer, capillary electrophoresis, …). Evaluation and implementation of new technologies and development of collaborations with subcontractors and other biotech and pharmaceuticals companies. Relationships with suppliers… Show more Leading a team of 6 technicians, engineers and Ph D. Managing the biochemistry lab particularly expression purification and quality control. Reporting. Purchasing and maintenance of lab equipment in the laboratory (FPLC, HPLC, spectrophotometer, 2D gel apparatus, densitometer, capillary electrophoresis, …). Evaluation and implementation of new technologies and development of collaborations with subcontractors and other biotech and pharmaceuticals companies. Relationships with suppliers. Implementation of a platform for protein expression in E. coli. Purification, formulation and functional and structural analysis of recombinant proteins expressed in prokaryotic and eukaryotic systems. Expression, purification, and structural analysis of monoclonal antibodies. Transfer of purification protocol to pilot unit. Engineering of recombinant antibodies (humanisation, chimeric). Analysis of cell lines and search of biomarkers by proteomic techniques (2D gels electrophoresis, DIGE technology, mass spectrometry). Quality control of proteins, antibodies, and peptides. Scientific consulting for other departments (in particular control quality department). Show less



Opsona Therapeutics

• Biotechnology
• 1 - 100 Employee

• Project Leader and next Consultant

  • Jan 2006 - Aug 2007

  Dublin, Irlande Setup of a proteomics lab. Training and supervision of scientists and technical personnel. Expression purification and analysis of secreted proteins from bacteria and parasites. Activity tests for proteins/enzymes (in vitro and in vivo). Interaction protein – protein. Proteomics (2D gels and mass spectrometry). Development of an anti-TLR2 antibody. Purchasing and maintaining of different equipments of protein purification and proteomics. Implementation of the CMC strategy and… Show more Setup of a proteomics lab. Training and supervision of scientists and technical personnel. Expression purification and analysis of secreted proteins from bacteria and parasites. Activity tests for proteins/enzymes (in vitro and in vivo). Interaction protein – protein. Proteomics (2D gels and mass spectrometry). Development of an anti-TLR2 antibody. Purchasing and maintaining of different equipments of protein purification and proteomics. Implementation of the CMC strategy and selection of CMO for the development of an anti-TLR2 antibody. Show less



Self Employed

• United States
• 700 & Above Employee

• Entrepreneurial Experience

  • Jul 2004 - Jul 2005

  Toulouse et périphérie Attempt to market the high throughput refolding process to European pharmaceutical companies.



Avidis SA

• Project Leader

  • Feb 2001 - Jun 2004

  Région de Clermont-Ferrand, France Expression, purification, refolding and biophysical and functional analysis of recombinant soluble and membrane proteins expressed in E. coli. Implementation of a robotic process which permits a high throughput analysis for protein refolding. Activity test for proteins and peptides in vitro and in vivo. Training and supervision of scientists and technicians in purification, refolding, and biophysical and functional analysis of proteins. Project management. SOP writing. Evaluation of new… Show more Expression, purification, refolding and biophysical and functional analysis of recombinant soluble and membrane proteins expressed in E. coli. Implementation of a robotic process which permits a high throughput analysis for protein refolding. Activity test for proteins and peptides in vitro and in vivo. Training and supervision of scientists and technicians in purification, refolding, and biophysical and functional analysis of proteins. Project management. SOP writing. Evaluation of new technologies. Development of collaboration with academic laboratory. Relationship with suppliers. Purchasing of medium scale equipment during start-up phase. Show less



McGill University

• Canada
• Higher Education
• 700 & Above Employee

• Project Leader

  • Sep 1997 - Dec 2000

  Région de Montréal, Canada Project: over-expression, purification, and functional and structural characterization of different members of the multidrug resistance protein family. These membrane transporters confer the resistance to anticancer drug by exclusion of these drugs from the targeted cancer cells. The goal was to better understand the structure and the activities of these glycoprotein transporters to synthesize chemical components able to block these transporters. For this study, these glycoproteins were… Show more Project: over-expression, purification, and functional and structural characterization of different members of the multidrug resistance protein family. These membrane transporters confer the resistance to anticancer drug by exclusion of these drugs from the targeted cancer cells. The goal was to better understand the structure and the activities of these glycoprotein transporters to synthesize chemical components able to block these transporters. For this study, these glycoproteins were over-expressed in yeast cells. Management of technicians and PhD student. Show less



Indiana University Bloomington

• United States
• Higher Education
• 700 & Above Employee

• Project Leader

  • Feb 1995 - Sep 1997

  Région de Bloomington, Indiana, États-Unis Project: purification and reconstitution of a phospholipid transporter from the plasma membrane of erythrocytes, obtaining of monoclonal antibodies which recognize and inhibit this membrane transporter. This membrane transporter plays a major role in different steps of the blood coagulation cascade and possesses Mg-ATPase activity regulated by its phospholipid environment.