Jean-Philippe Taquet Email & Phone Number

Visp, Vs, Ch

Basel, Ch

Regulatory CMC: Preparation and/or review of regulatory pharmaceutical documents for small molecules, drug linkers and antibody-drug conjugates: CMC sections of IMPD/IND/NDA/MAA, CTD module 3, US/EU DMF, Quality Overall Summary of MAA, CMC sections of Scientific Advices. Responses to Ad hoc questions and to Grounds for Non-acceptance from the regulatory authoritiesRegulatory Project Management for development and marketed drug substances Regulatory support and ad-hoc advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questionsSupport site specific regulatory documents (RA process implementation, Change Control Management, new requirements implementation and follow-up) Regulatory advice to functional areas on site

Basel, Ch

Paris, Paris, Fr

Preparation and/or review of regulatory pharmaceutical documents for small molecules, chemical peptides and antibody-drug conjugates: CMC sections of IMPD/IND/NDA/MAA, CTD module 3 (included variations), US/EU DMF and Quality Overall Summary of MAA. Preparation and/or review of answers to Quality questions during assessments of dossiers by regulatory agencies.Scientific advices meeting preparation (preparation of questions, company’s positions and of CMC scientific background)Global CMC regulatory strategy, in particular for APIs development, manufacturing and site transfer.Answers to Ad hoc CMC questionsSupport to selection and management of contracting activities to CROs/CMOs and technology transfer. Follow-up and monitoring of the CMC development within selected CMOs.Regulatory Intelligence: Preparation of the biweekly Regulatory Information Bulletin and of the specific monthly Biosimilar Regulatory Bulletin

Saint Cloud, Fr

Brig, Valais, Ch

Chemist responsible for process research and development in organic synthesis: supervision of a laboratory technicians’ team, project management, coordination with QC, QA, and production teams. Written and oral communication with international customers.Custom Synthesis, technical and economic feasibility studies of new molecules and key-intermediates following RFPs from customers from Pharmaceutical and Chemical Industries. Development and optimization of industrially viable synthetic process for new molecules. Optimisation of the existing processes and production trouble-shooting resolution. Redaction of the development reports, of pilot production documents and the documentation for production transfer (CKL, OPM, process risk analysis), Assistance to transfer in production.

Bubendorf, Ch

Chemist responsible for API chemical and process development (including peptide liquid phase synthesis): supervision of a laboratory technicians’ team, project management, coordination with QC, QA, and production teams.Development Projects Management: Internal coordination with commercial, analytical, quality, production and regulatory Teams; external coordination with clients.Custom Synthesis, technical and economic feasibility studies of Generic Active Pharmaceutical Ingredients (API) and New Chemical Entities (NCE).Development and optimization of industrially viable synthetic process for the new active pharmaceutical ingredients under cGMP conditions. Lab work in 1 to 10L reactors. Optimisation of the existing processes and production trouble-shooting problems resolution.Management and coordination of the out-sourcing at different CMOs of some API intermediates for the chemical and process development parts Redaction of the development reports and the cGMP documentation for production transfer (MPR, process risk analysis and quality risk analysis). Assistance to transfer in pilot-plant and production. Compilation of the CMC part in the regulatory files (DMF and CEP).Redaction of a process part for a patent.

Fr

- Responsable Synthèse Chimique : Synthèse multi-étapes, pré-développement et scale-up de nouvelles molécules énergétiques du type hétérocycles azotés (bitriazoles, pyrazoles, furazanes). ; développement et amélioration de procédés bas-coût en chimie des dinitramines.- Développement de projets R&D, recherches bibliographiques, rédaction de rapports techniques.

- Synthèse multi-étapes d’hétérocycles hautement colorés fluorescents (phthalocyanines) et couplage sur des hexapeptides. Etude photophysique pour une application en thérapie photodynamique contre le cancer

- Synthèse multi-étapes de ligands phosphoramidites et oléfiniques chiraux. Application en catalyse de substitution allylique asymétrique : Développement de nouvelles méthodes catalytiques de synthèse énantiosélective d’amines et d’esters allyliques d’intérêt pharmaceutique sous conditions industrielles.- Etude mécanistique du cycle catalytique.

Doctorat, Chimie

Ingénieur, Chimiste