PpbBracco /b is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group’s main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements. /p h3About the role /h3 pThe role is based on significant knowledge and experience in Chemistry, Manufacturing, and Controls (CMC) for X-ray and MRI Drug Substances and Drug Products. The Specialist acts as a bridge between Radiology Optical Imaging RD, Global Technical Operations (GTO), Corporate Quality Management (CQM), and Regulatory Affairs (RA), supporting product development from early stages through approval and post-approval, and contributing to cross-functional teams by preparing and reviewing relevant technical documentation. /p pThe role can be based either at our Milan office or in Colleretto Giacosa (TO). /p h3Key Responsibilities /h3 ul liWrite, review, and support execution of protocols and preparation of reports for analytical validation and technical transfer to GTO QCs, CMOs, and external labs. /li liSupport Regulatory Affairs in preparing CMC sections of regulatory submissions and responding to authority requests. /li liProvide technical expertise in cross-functional working groups on CMC topics, including guideline implementation, development projects, and inspections. /li liAssist QCs, partners, and CMOs in change control, troubleshooting, and compliance activities. /li /ul h3Qualifications /h3 pRequired: /p ul liMS (Laurea Magistrale) in Chemistry, Pharmaceutical Chemistry, or related scientific disciplines. /li liMinimum 5 years’ experience in CMC topics within RD or Operations (Analytical Development, QC Labs, Pharmaceutical Development, or Process Chemistry). /li liProficiency in English and Italian (spoken and written). /li /ul pPreferred: /p ul liValidation and technical transfer processes /li liImpurity profiling (process, degradation, elemental, mutagenic impurities, nitrosamines) /li liStability studies /li liPrimary packaging and plastic material qualification (compatibility, extractables leachables, functionality/integrity) /li liSpecification definition and justification /li /ul h3Soft Skills Values /h3 ul liTeamwork, transparency, and proactive attitude /li liReliability, precision, and willingness to learn /li liResults-oriented and deadline-driven /li liFlexibility and adaptability to change /li liPrioritization and decision-making /li /ul pIf you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now! /p pAt Bracco, we believe in the values of diversity and inclusion. We respect and celebrate the diversity of our people and their experiences, ensuring a fair opportunity for all. /p /p #J-18808-Ljbffr