CMC Life-Cycle Management Specialist

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.

The 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 Responsibilities

• Write, 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.

Qualifications

Required:

• 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 processes

• Impurity profiling (process, degradation, elemental, mutagenic impurities, nitrosamines)

• Stability studies

• Primary packaging and plastic material qualification (compatibility, extractables & leachables, functionality/integrity)

• Specification definition and justification

Soft Skills & Values

• Teamwork, transparency, and proactive attitude

• Reliability, precision, and willingness to learn

• Results-oriented and deadline-driven

• Flexibility and adaptability to change

• Prioritization and decision-making

If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now!

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