Daniele Rizzo

Team leader of analytical project leaders unit (7 direct report) focused on support drug development program in the analytical field.

Main task

• Streamlined operations for improved efficiency, delegating tasks and setting clear performance expectations.
• Analyzed metrics to identify areas of opportunity, drive performance improvements and consistently exceed operational goals.
• Mentored junior team members for accelerated professional growth and skill development.

Recent accomplishment

• Support the successful implementation of new LIMS, minimizing disruptions during transition periods while maximizing benefits realized postimplementation.

With over five years of experience, I have successfully managed and provided support for more than 20 drug development programs, encompassing various aspects such as API manufacturing, formulation development, clinical manufacturing, preclinical toxicology studies, and regulatory submissions across multiple regions including the United States, European Union, Australia, Brazil, and others.

Notably, participated in a pre-IND meeting with the USP to propose specifications for a complex drug substance impurity profile, demonstrating my expertise in regulatory matters.

Main Taks

• Managed team meetings and discussed project's milestone and key relevant
• Successfully led multiple projects simultaneously while maintaining a focus on priorities, resource allocation, and overall strategic objectives.
• Analytics: support method development and validation, Formulation development with prototype characterization and clinical manufacturing with release analysis and product specification definition

Development, Validation and tech. transfer of new method to be applied in Quality Control laboratory.

Analyst at Validation laboratory.

• HPLC analysis regarding stability study, cleaning process and analytical method validation
• Participated in regular audits to maintain compliance with regulatory standards and ensure laboratory safety protocols were upheld.
• Analysis according European Pharmacopoeia in the incoming materials quality control field.
• Method Validation