- Management of the professional relationship with the Clients through organization of conference calls and onsite meetings- Authoring of CTD sections (Module 3) for US and EMA and supporting Request for Information (RI) from Health Authorities- Preparation of submission packages for AIFA with several scopes (e.g. Active Ingredients Importations, Manufacturing Authorization...)

- Failure Mode and Effect Analysis development and drafting for processes designed in the manufacturing plant- Drafting of validation documentation for Process & Cleaning for sterile dosage forms (liquid and lyophilized)Shop floor support during manufacturing, overseeing production personnel to ensure correct application of validation parameters- Troubleshooting and cross-functional interaction with other Departments to support investigations and deviation closure

- Development of injectable dosage forms (antiproliferative, cytotoxic and cytostatic drugs) Department representative for Development Lab for down-scale conjugation and lyophilization process studies- Scale-up of conjugation processes in GMP manufacturing areaLyophilization cycle optimization through Differential Scanning Calorimetry and Freeze- Drying Microscopy- Use of pilot-scale freeze-drier for the production ofdevelopment lyophilization batches- Drafting of GLP documents: Experimental- Development Proposals/ReportsOptimization of lyophilization-conjugation processes based on the manufacturing plant and equipment features