Alessandro Conte Email & Phone Number

Osimo, It

Ancona, Marche, Italia

Development of new products process and formulations based on industrial production needs  Management of the projects with multifunctional teams to define and achieve in the correct time the deliverables of the projects itself. Formulation and process design to achieve the best industrial efficiency and quality of the new products o Design of Stability predicted stress testing evaluationo Standalone experiments and DoEo Preparation of labo and pilot scale batcheso Raw materials advanced characterization and definition of technological specifications

Ancona, Marche, Italia

Management of multifunctional teams for industrial operations projects: Project leader of: o Reengineering projects of already manufactured products (change in formulation and process)o Scale up o Technology transfer In and Out Project management using Planisware software (Gantt, work breakdown structure, milestones identification, risk management etc)  Coordination of the Team to achieve the required results in the correct timeTechnology Transfer and process development  Perform trial batches at labo and pilot scale to understand the Critical Process parameters of the manufacturing process and critical quality attributes of the drug products. Individuate parameters set up on the industrial scale machine to guarantee efficiency of the process and quality of the final drug products. Process development on the basis of Lean principia (SMED, Five S, spaghetti charter, Takt time, value stream mapping etc) Management of the workers during industrial trials and Training on the final desired processTroubleshooting and Production support Troubleshooting and production support to eliminate waste and improve efficiency and quality of the new and already existing process (root cause analysis, management of process change to shoot the manufacturing problems etc)Project management for the introduction of new suppliers’ raw materials Selection of new suppliers based on technological properties  Advanced characterization of raw materials:o particle size and particle shape evaluation by optical and laser scattering instrumentso powder flow and Rheology behavioro traditional technological tests Definition of technological specification of raw materials  Management multifunctional activities needed for the introduction of the supplier by change control.

Ancona, Marche, Italia

Junior technology transfer and process development specialistManage the introduction of new suppliers raw materials Selection of new suppliers of already used raw materials based on Technological and Regulatory assessment Management multifunctional activities by change control. Galenic worker at Clinical Trials Department Production and packaging of clinical trial batches Creation and revision of SOP concerning equipment in Clinical Trials DepartmentTechnology transfer and process development specialist Training on process scale up, technology transfer and troubleshooting.  Technological characterization of solid and liquid dosage forms

Stage in Technology transfer and process development department:Technological and regulatory assessment of raw materials by new suppliers Technological characterization of API and excipients  Regulatory compliance assessment on API and Excipients (compliance with Ph.Eur, Dossier, ICH guidelines, EU directive, CEP, non compendial analytical methods etc) Technical data sheets of raw materials:  To Request to the suppliers and evaluation of lacking or updating documentation (compliance with the current guidelines) To Share with the suppliers: Chemical, microbiological and technological specifications (on the basis of Ph.Eur, dossier, CEP, internal requirements)Training on process scale up and technology transfer, for solid dosage forms and technological characterization of granules and mixtures