Consultant, Pharma Biotech

Phone: +44(0)1751 432999
Country: Italy

Marco Budini has over 30 years of experience in the pharmaceutical and biotechnology industry. As an independent consultant, he covers pharmaceutical technology and compliance topics, including expertise and guidance on FDA and EU current Good Manufacturing Practices (cGMPs).

He was with Eli Lilly, Italy, for over 20 years, covering several assignments in quality control, quality assurance and manufacturing in the roles of Chemical Laboratory Head, Injectable Products Manufacturing Head, QA Manager and Technical Service and Validation Advisor.

More recently, Mr. Budini was Head of Quality Operations – Secondary Manufacturing with Novartis Vaccines (formerly Chiron Vaccines).

He has served as past Vice President of the Parenteral Drug Association-Italy Chapter and was a lecturer with the Florence University on validation topics.

His areas of expertise include:

  • Aseptic and sterile processing
  • Qualification and validation
  • Deviation management and investigation
  • GMP audits of facilities, operations, quality systems and vendor/third-party/contract manufacturing
  • In-house training on cGMPs, environmental monitoring, aseptic practices and quality systems