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Scientist - Drug Product Manufacturing & Development - Iceland
Posted on : 10 July 2017
- Manage the pharmaceutical development aspects of a bio similar 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 bio similar 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.