Emanuela Ungarelli Email & Phone Number

Sermoneta, Lazio, It

Latina, Lazio, Italia

Latina

 project assessment/Cost Calculation of strategic products evaluated as part of the corporate’s team feasibility assessment of new product introduction linked to a new fill and finish line for injectable vials and pre filled syringes (main category of products are vaccines and biological) Leading of several complex projects related to the introduction of commercial products with significant capex investment and particular challenges in analytical tech-transfer.

Latina, Lazio, Italia

 Introduction of new oral projects and small molecule injectable products (project feasibility assessment, timeline definition and budget monitoring) Coordination of a project specialist group

PM for technology transfer of Injectable (lyo and liquids), oral and ADC products Main customer's contact person to evaluate the technical features and fix issues linked to the product transfer (materials/equipment selection, process feasibility, analytical methods transfer, production MBR supervision, monitoring of the aspects of quality compliance and product validation ). Issuing of Project and all project linked Change Controls Supervision of the manufacturing processes… Show more PM for technology transfer of Injectable (lyo and liquids), oral and ADC products Main customer's contact person to evaluate the technical features and fix issues linked to the product transfer (materials/equipment selection, process feasibility, analytical methods transfer, production MBR supervision, monitoring of the aspects of quality compliance and product validation ). Issuing of Project and all project linked Change Controls Supervision of the manufacturing processes during the execution of the clinical, validation or registration of the product itself. Supporting the team during regulatory and client audits Effective partecipation for troubleshooting of technical and quality issues linked to the project Filing and distribution of the project documentation Leading Steering committee and Quarterly meeting Involvement in the Budget definition and continuos project cost monitoring during its life cycle Direct staff selection and coaching Show less

Definizione del flusso dei campioni nel sistema LIMS (dal campionamento all' approvazione) e implementazione di tale sistema aziendale.Redazione delle specifiche analitiche.Redazione di dossier tramite e-ctd.

Supervisore del laboratorio QCChimico di BSPPharmaceuticals. Definizione e scrittura delle SOP di laboratorio e del reparto QC Ambito Transfer Analitico, Validazione metodi, Stabilità, Gestione Calibrazioni/Manutenzioni strumenti, Acquisto e monitoraggio della qualifica dei nuovi strumenti (laboratorio da strutturare)

Supervisore di Stabilità e Cleaning Validation presso il laboratorio QC di Patheon Ferentino