Dr. Massimo Trofino

I drive the management of QC analytical lab of the manufacturing site. The group is responsible for the release and stability analysis of all products manufactured on site. Moreover I collaborate with the R&D and Regulatory Affairs departments. In this role I gained considerable experience in dealing with Data Integrity issues and have an important role in the relationship with the company’s main customer Sanofi.

Pharmanalytica SA is the European Stability Centre of Novartis. It is located in Locarno, Switzerland. I coordinated the activities of one of the centre’s QC analytical labs. The group was responsible for executing several important projects (e.g. Stability Commitment, Follow-up Stability Studies, Registration Stability Studies) conducted in Locarno. My responsibilities included the scheduling of activities on the basis of expected workload.

Responsible for the Batch Release of medicinal products, medical devices and cosmetics manufactured in the company. Management of Quality System according to cGMP and ISO 13485.

pre clinical DMPK, in vitro studies, ex-vivo studies, PK/TK modeling, chromatography, HPLC, radioactive compounds, GLP, protocol and report writing, study planning

Bioanalytical activity in clinical studies.

Validation of new HPLC-UV and GC-FID methods and their application in the analysis of biological samples (study of environment and life quality).

Pharmaceutical chemistry