Cmc Life-Cycle Management Specialist
2 giorni fa
Bracco 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.About the roleThe 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 R&D, 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.The role can be based either at our Milan office or in Colleretto Giacosa (TO).Key ResponsibilitiesWrite, review, and support execution of protocols and preparation of reports for analytical validation and technical transfer to GTO QCs, CMOs, and external labs.Support Regulatory Affairs in preparing CMC sections of regulatory submissions and responding to authority requests.Provide technical expertise in cross-functional working groups on CMC topics, including guideline implementation, development projects, and inspections.Assist QCs, partners, and CMOs in change control, troubleshooting, and compliance activities.QualificationsRequired:MS (Laurea Magistrale) in Chemistry, Pharmaceutical Chemistry, or related scientific disciplines.Minimum 5 years' experience in CMC topics within R&D or Operations (Analytical Development, QC Labs, Pharmaceutical Development, or Process Chemistry).Proficiency in English and Italian (spoken and written).Preferred:Validation and technical transfer processesImpurity profiling (process, degradation, elemental, mutagenic impurities, nitrosamines)Stability studiesPrimary packaging and plastic material qualification (compatibility, extractables & leachables, functionality/integrity)Specification definition and justificationSoft Skills & ValuesTeamwork, transparency, and proactive attitudeReliability, precision, and willingness to learnResults-oriented and deadline-drivenFlexibility and adaptability to changePrioritization and decision-makingIf you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply nowAt 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.#J-*****-Ljbffr
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Global Regulatory Cmc Lead — Compliance
6 giorni fa
Lazio, Italia Jefferson Wells A tempo pienoUn'azienda del settore farmaceutico cerca un Global Regulatory CMC Specialist per supportare la gestione delle registrazioni di prodotti globali.I compiti includono la preparazione e revisione delle sezioni CMC per nuove registrazioni, garantendo la compliance globale e conducendo analisi gap dei dossier.L'ideale è un candidato con esperienza nel settore...
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Director Life Cycle Service
7 giorni fa
Lazio, Italia Kardex A tempo pienoSocial network you want to login / join with : Kardex Remstar is a leading Swiss company and global market leader in warehouse automation and intralogistics systems, with over 2,500 employees worldwide.Our excellent reputation is built on the high quality of our products and services.At Kardex, you get the freedom to truly shape your ideas and vision in an...
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Director Life Cycle Service
4 giorni fa
Lazio, Italia Lexroom A tempo pienoKardex Remstar is a leading Swiss company and global market leader in warehouse automation and intralogistics systems, with over 2,500 employees worldwide. Our excellent reputation is built on the high quality of our products and services. At Kardex, you get the freedom to truly shape your ideas and vision in an inspiring and motivating work environment,...
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Director Life Cycle Service
2 giorni fa
Lazio, Italia Kardex A tempo pienoSocial network you want to login / join with : Kardex Remstar is a leading Swiss company and global market leader in warehouse automation and intralogistics systems, with over 2,500 employees worldwide.Our excellent reputation is built on the high quality of our products and services.At Kardex, you get the freedom to truly shape your ideas and vision in an...
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Director Life Cycle Service
4 giorni fa
Lazio, Italia Lexroom A tempo pienoKardex Remstar is a leading Swiss company and global market leader in warehouse automation and intralogistics systems, with over 2,500 employees worldwide.Our excellent reputation is built on the high quality of our products and services.At Kardex, you get the freedom to truly shape your ideas and vision in an inspiring and motivating work environment, based...
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Cmc Lifecycle Lead – Imaging Drug Substances
2 giorni fa
Lazio, Italia Bracco Imaging A tempo pienoA leading healthcare group located in Italy is seeking a Chemistry Specialist with significant experience in Chemistry, Manufacturing, and Controls (CMC) for X-ray and MRI products.The ideal candidate will support product development and participate in cross-functional teams.A master's degree in Chemistry and at least 5 years of related experience are...
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Biomedical Qa
2 settimane fa
Lazio, Italia Engie Italia A tempo pienoA multinational pharmaceutical company is seeking a CMC Senior Specialist in Bresso, Italy.The role involves managing regulatory submissions and ensuring compliance with cGMP and FDA standards.Candidates should have a degree in Life Sciences and over 5 years of Regulatory Affairs experience.Excellent English communication skills are essential.This full-time...
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Fleet Management
2 settimane fa
Lazio, Italia Ayes - Management & Technology Consulting A tempo pienoFai la differenza con AYES: unisciti come FLEET MANAGEMENT & AUTHORITY SERVICE SPECIALIST!AYES, multinazionale di consulenza ingegneristica e tecnologica, in vista dell'espansione delle proprie attività in Italia, è alla ricerca di un Fleet Management & Authority Service Specialist !AYES opera a livello globale, offrendo soluzioni avanzate e progetti...
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Fleet Management
2 settimane fa
Lazio, Italia Ayes - Management & Technology Consulting A tempo pienoFai la differenza con AYES: unisciti come FLEET MANAGEMENT & AUTHORITY SERVICE SPECIALIST!AYES, multinazionale di consulenza ingegneristica e tecnologica, in vista dell'espansione delle proprie attività in Italia, è alla ricerca di un Fleet Management & Authority Service Specialist !AYES opera a livello globale, offrendo soluzioni avanzate e progetti...
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Fleet Management
2 settimane fa
Lazio, Italia Ayes - Management & Technology Consulting A tempo pienoFai la differenza con AYES: unisciti come FLEET MANAGEMENT & AUTHORITY SERVICE SPECIALIST!AYES, multinazionale di consulenza ingegneristica e tecnologica, in vista dell'espansione delle proprie attività in Italia, è alla ricerca di un Fleet Management & Authority Service Specialist !AYES opera a livello globale, offrendo soluzioni avanzate e progetti...
