Beschreibung
Responsibilities:- Provide expertise to support the selection process of Drug Product CMO
- Manage externalised manufacturing enabling activities relevant to drug product for the companies portfolio
- Define the planning and organisation of tech transfer activities with the CMC project leaders
- Lead and manage the technology transfer from Process Sciences to the manufacturing team, and external CMOs for Phase I, Phase II and Phase III production
Requirements:
-
PhD in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 3 years of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 6 years industrial experience -
Experience in technology transfer and management of drug product manufacturing -
Experience with monoclonal antibodies -
Knowledge of process control methods and process validation -
Strong knowledge of GMP -
Experience in protein formulation and drug product development for both early and late phase development (Phase 1 to BLA) - Fluency in English, both written and verbal; French is a plus