Required experience- Pharma GMPs main regulations knowledge with at least 8 years experience preferably in role of Manufacturing Science and Technology or Process Validation subject matter expert- Experience in manufacturing of complex pharmaceutical forms such as aseptic process of drug product, lyophilized products, biological products- Process Validation and Continuous Process Verification- Filter Validation- Single use manufacturing systems- Aseptic Manufacturing and Media simulation study- experience in Technology Transfer team (at least 3 years)- Experience in project management in Technology Transfer projects or similar context- Risk management - Documentation Management (SOPs, Specification, Records) - Deviations/Non-conformities management - Data integrity- use of statistical tools and software Other Desired Experience:- experience in biotechnology/ biosimilar products (Cell and gene therapy; Cell culture expansion, harvest, purification, formulation, fill and finish; Blood plasma fractionation and component purification)- experience in solid oral pharmaceutical forms- Product Quality review- Developing Validation / Verification Master Plans- Performing formal risk assessments / FMEA- Change Control - CAPA process - Identifying Critical Attributes and Critical Process Parameters- Commissioning and Qualification- Developing User Requirements- Schedule development and execution- Establishing metrics and leading team to achieve performance goals- Facilitating meetingsLa selezione rispetta il principio delle pari opportunità (l. 903/77)#LI-AG1