Experience

Eurofins BioPharma Product Testing Italy

• Italy
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Scientific Director for Advanced Therapies & ATMP QP

  • May 2020 - Present



MolMed now part of AGC Biologics

• Italy
• Biotechnology Research
• 1 - 100 Employee

• Project Manager and Qualified Person

  • Jul 2017 - May 2020

  Cell and gene therapy field: Project Manager and Qualified Person QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP). The process of batch release comprises of: -The checking of the manufacture and testing of the batch in accordance with defined release procedures. -The certification of the finished product batch signifying that the batch is in compliance with GMP and the requirements of its MA. This represents the quality release of the batch. -The transfer to saleable stock, and/or export of the finished batch of product which should take into account the certification performed by the QP. If this transfer is performed at a site other than that where certification takes place, then the arrangement should be documented in a written agreement between the sites. Show less



MolMed now part of AGC Biologics

• Italy
• Biotechnology Research
• 1 - 100 Employee

• Project Manager

  • 2015 - 2017

  • Formulate and inspire a scientifically sound and business driven project strategy including risk assessments and contingency planning in collaboration with the General Manager, R& D and Business Development. • Understand and proactively manage the cross-functional aspects of assigned project(s) among R& D Department and with other functions (e.g. Regulatory, Safety, Clinical, Operations) • Lead, represent, manage and support the project team for selected project(s), with strong strategic focus, quality awareness, management capabilities, scientific and technical expertise • Support the development of novel technologies for product knowledge and advancement • Monitor project progress on activities, responsible for budget, staffing, performance reviews, goals, and training • Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, customer and stakeholders Project Manager for all GSK projects in Advanced therapies included in the strategic agreement signed in 2015 and concerning MolMed’s supply of development, manufacturing and technology transfer services for the clinical application of gene therapies based on viral vector cellular transduction. Show less



MolMed now part of AGC Biologics

• Italy
• Biotechnology Research
• 1 - 100 Employee

• Head of Process Development

  • 2011 - 2014

  • Process, testing design and development for production and release of GMP Medicinal Products to be prepared in the contest of phase I-II-III Clinical trials and Market application, for cell and gene therapy applications in the field of Advanced Therapies. • Retroviral and Lentiviral processes scale-up (from small scale to large and full scale), down-stream of the process to obtain vector material for Medicinal Product preparation (genetically modified cells). • Cell transduction processes development and optimisation for Medicinal product preparation of genetically modified Haematopoietic Stem Cells and T-Lymphocytes • Gap analyses, team building and restructuring for sustainability and scalability • Technology transfer and comparability experienced. • Process validation and product control strategy involvement for different projects • Analytical cellular, biochemical and Immuno-enzymatic assays development and qualification according to international guidelines. • Authoring and reviewing regulatory filings. I have worked with GSK team for the development of ex vivo gene therapies for rare genetic disorders specifically for Strimvelis, and with TIGET for MLD, and WAS during clinical trial phases. Within the ADA-SCID project (for Strimvelis DP) my role was in the leading of MolMed process development team, developing and optimizing the vector and cell transduction processes for CD34+ haematopoietic stem cells (HSCs) Medicinal Product GMP manufacturing. Our work was sufficient for commercial supply with changes made to both vector and drug product manufacture. Show less



MolMed now part of AGC Biologics

• Italy
• Biotechnology Research
• 1 - 100 Employee

• Senior researcher/project manager

  • 2006 - 2010



MolMed now part of AGC Biologics

• Italy
• Biotechnology Research
• 1 - 100 Employee

• Development researcher/project planner

  • 1999 - 2005



MolMed now part of AGC Biologics

• Italy
• Biotechnology Research
• 1 - 100 Employee

• GMP manufacturing supervisor

  • 1996 - 1998



Istituto San Raffaele Telethon per la Terapia Genica (SR-TIGET)

• Milan Area, Italy

• Fellowship in AIDS research from Istituto Superiore di Sanità (Italy)

  • 1994 - 1996



Istituto San Raffaele Telethon per la Terapia Genica (SR-TIGET)

• Milan Area, Italy

• Fellowship in Haematological field

  • 1993 - 1993



Università degli Studi di Verona

• Italy
• Higher Education
• 700 & Above Employee

• Fellowship in Immunological field

  • 1989 - 1992