Drug Product Development Scientist

CordenPharma Caponago IT

CordenPharma Caponago IT

Corden Pharma Caponago, è un Sito produttivo farmaceutico, di una ampia gamma di liquidi sterili iniettabili, con esperienza specifica in sterilizzazione terminale, produzioni sterili “fill&finish” e tecnologie di emulsioni sterili. Il sito offre una vasta gamma di competenze che includono lo Sviluppo formultativo, la produzione, il confezionamento e la gestione logistica del farmaco. Precedentemente come sito produttivo AstraZeneca, CordenPharma Caponago porta più di 20 anni di esperienza a Corden Pharma nell’offerta come “full-service CDMO”. Il Sito è ispezionato dall’EMEA (AIFA), FDA, ANVISA, TGA e le Autorità Giapponesi.

Summary

Reporting directly to the R&D Manager of Corden Pharma Caponago, a plant dedicated to the contract development and manufacturing of injectable drugs in aseptic or terminal sterilization technology:

Main activities:

• >> Planning, coordinating and documenting, in collaboration with the R&D team and under the supervision of the R&D Manager, pharmaceutical development activities, process materials testing, process simulations;
• >> Collaborating with customers, Project Manager and the projects team in the Project Planning and in the drafting of documents to support pharmaceutical development activities and technology transfer/industrialization of pharmaceutical manufacturing processes (Product Development Protocol/Report, Technology Transfer Plan/Report, etc.).
• >> Performing experimental laboratory focused on formulation/process development and characterization trials;
• >> Managing the manufacture of development and/or engineering/clinical batches, coordinating the support staff.
• >> Managing the training of the production operators for the internal technology transfer from development to commercial manufacturing, taking care also of safety aspects.

Skills:

• >> University degree in scientific subjects with 3/4 years’ experience in pharmaceutical production;
• >> Very good knowledge of MS- Office tools
• >> Excellent communication (both written and oral) skills in English;
• >> Previous experience in in injectable formulation development is highly desired;
• >> Previous experience in DP technology transfer is a plus;