Drug Product Tech Transfer Consultant/Manager

Vertragsart:
Vor Ort
Start:
01/2019
Dauer:
12 Months
Von:
Glocomms
Ort:
Switzerland
Eingestellt:
12.01.2019
Land:
flag_no Schweiz


Projektbeschreibung

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