Key Responsibilities:

• Act as an expert in all sterile manufacturing and sterility assurance related topics, supporting both TRD RLT Pilot Plant operations and the global network.
• Participate in the build-up of the TRD RLT Pilot Plant, offering sterile/aseptic manufacturing expertise and developing the plant contamination control strategy.
• Promote and share best practices, bringing robust scientific and technical expertise.
• Present scientific/technical results internally and externally, contributing to publications.
• Contribute as an author or reviewer to the creation of standard operating procedures (SOPs).
• Lead or partake in investigations, corrective actions, and project risk assessments, offering microbiology-related solutions.
• Perform EM trend analysis and support related preventive and corrective actions.
• Communicate critical topics promptly to the Analytical Project Leader and other relevant team members.
• Support internal and external audits, ensuring no critical findings, and uphold collaboration with testing laboratories while respecting industry standards and internal guidelines.

Essential Requirements:

• Holding a PhD, diploma, bachelor, or master's degree in microbiology/biotechnology or a related field.
• Prior experience in Sterility assurance related topics within the pharmaceutical industry/GMP.
• Fluency in English (oral and written) and proficiency in Italian.
• Solid understanding of quality principles such as GMP and quality expectations.
• Excellent communication skills, including presentation and scientific/biotechnical writing.
• Ability to work effectively and proactively in a multidisciplinary team.
• Experience in Bacterial endotoxin, Sterility, and Bioburden testing is desirable.
• Knowledge and experience in the field of Radiopharmaceuticals and radioprotection practices would be a plus.