Experience

Corteria Pharmaceuticals

• France
• Biotechnology Research
• 1 - 100 Employee

• CMC Lead

  • Jan 2023 - Present

  ∙ Lead from Drug Substance (DS) synthesis to Investigational Medicinal Product (IMP) Release for Clinical Studies: DS manufacturing and control, Drug Product development, IMP production, IMPD writing, clinical study, budget, timelines. ∙ Peptides, Antibody, Injectables ∙ CMC strategy, Supplier selection ∙ Board reporting, Due Diligence Response to Questions ∙ QA system implementation ∙ Lead from Drug Substance (DS) synthesis to Investigational Medicinal Product (IMP) Release for Clinical Studies: DS manufacturing and control, Drug Product development, IMP production, IMPD writing, clinical study, budget, timelines. ∙ Peptides, Antibody, Injectables ∙ CMC strategy, Supplier selection ∙ Board reporting, Due Diligence Response to Questions ∙ QA system implementation



SUBSTIPHARM

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmaceutical Development PM

  • Nov 2016 - Dec 2022

  • Feasability study: development strategy definition (including QbD), offers review and negotiations, CDMO/CMO/supplier selection, R&D agreement • Project management from lab to industrial scale batches: formulation & production documentation validation, material supply, Bio- or in-vitro equivalence studies coordination, budget, timelines, KPI definition, MA file review, deficiency letter answer writting • Transversal team coordination between leads and experts: formulation, analytical, clinical, QA, CMC, CDMO, CMO, CRO, suppliers… • Interns and newly hired people management Show less



BIOGARAN

• France
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Technological Transfer and Industrialization Project Manager

  • Apr 2012 - Nov 2016

  - Management of several projects : dealing with all technical aspects of developpement, industrilization, and launch of new products, transfer of production, addition of new API sources. - Approval of all related documents (BMI, BPI, validation protocol and reports). - Writting of 3.2.P.3. part of the MA file. - Quotation requests for the transfer of production and offers analysis. - SOP writting. - Management of several projects : dealing with all technical aspects of developpement, industrilization, and launch of new products, transfer of production, addition of new API sources. - Approval of all related documents (BMI, BPI, validation protocol and reports). - Writting of 3.2.P.3. part of the MA file. - Quotation requests for the transfer of production and offers analysis. - SOP writting.



Laboratoire de Physico-chime - Pharmacotechnie - Biopharmacie - UMR CNRS 8612

• PhD - Pharmacotechny and Biopharmacy

  • Oct 2007 - Feb 2011

  Chargée de mettre au point des formules d'émulsions naturelles H/E stabilisées par des protéines et des polysaccharides en vue d'applications pharmaceutiques ou cosmétiques. Caractérisations physico-chimiques des émulsions, synthèse et analyse critique des résultats obtenus. Présentations et publications de ceux-ci au sein d'articles scientifiques et/ou lors de congrès internationaux. Egalement en charge de stagiaires tout au long de mon projet. Chargée de mettre au point des formules d'émulsions naturelles H/E stabilisées par des protéines et des polysaccharides en vue d'applications pharmaceutiques ou cosmétiques. Caractérisations physico-chimiques des émulsions, synthèse et analyse critique des résultats obtenus. Présentations et publications de ceux-ci au sein d'articles scientifiques et/ou lors de congrès internationaux. Egalement en charge de stagiaires tout au long de mon projet.


WYETH Research
• Formulation Development Intern

  • Jun 2006 - Sep 2006