Vaccine Process Expert (m/f)

With 30,000 employees in 70 countries, Takeda is one of the most innovative pharmaceutical companies in the world. We develop active pharmaceutical ingredients and integrated therapy approaches against diseases for which there is no cure for yet. Every day, our employees take on responsibility for more health. From prevention to treatment to care. In doing so, we pursue one objective: to improve people’s lives. In Germany, about 2,000 people at four locations support us on this mission. Become a part of Takeda and help us create tomorrow’s health solutions.
We are looking for

candidate

for the position Vaccine Process Expert (m/f) within the department

GMS – TaSiVa (Takeda Singen Vaccine)

. The position is based in

Singen

, Germany.
Your Responsibilities

 

Project-Phase:

 

  • Develops vaccine activity targeting model for Takeda´s new drug product manufacturing site in Singen
  • Develops “time out of refrigeration” for drug product manufacturing and packaging and compares with the current model
  • Sets up activity critical process parameters for manufacturing transfer, validation and routine production
  • Contact person for Takeda´s Vaccine Business Unit for  drug product bulk manufacturing process transfer including vaccine specific know-how
  • Prepares registration documents for drug product manufacturing

 

Production-Phase:

 

  • Management of vaccine specific changes, deviations and CAPAs
  • Controls “time out of refrigeration” for drug product manufacturing and packaging
  • Controls registration documents for drug product manufacturing

 

 

 

 

Your Profile

 

 

 

  • Master of Biotechnology, Biology or similar education
  • Experience with pharmaceutical formulations and processes preferable
  • Experience in writing registration documents
  • Experience in GMP regulated environment preferable
  • Fluent in English and German