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Scientist - Drug Product Manufacturing & Development Reykjavík Iceland,  


Posted on : 10 July 2017

Project Description

Manage the pharmaceutical development aspects of a biosimilar development project as a drug product subject-matter-expert in a cross-functional team. Design, perform, interpret and report experiments for the pharmaceutical development of biosimilar pipeline products, specifically leading the development of stable liquid formulations, selection of raw material qualities. Develop and characterize robust manufacturing processes for the filling of syringes and vials according to QbD principles and internal policies. Support drug product manufacturing process transfers from development to production. Support process validation, specifically driving process risk assessments, attending production runs, evaluating large-scale data in close collaboration with production-site team. Generate scientific documents, support the generation of international registration documents, support registration activities. Apply

Locations

101 Reykjavík Iceland

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