Aseptic Production Specialist

1 week ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

About the Position
Are you motivated by collaboration with internal stakeholders and Contract Manufacturing Organisations (CMO) globally? Do you have experience with aseptic production and a strong interest in working with drug candidates in clinical development?
We are hiring new colleagues to build up competences and ramp-up for exciting activities at CMO's around the world.

Main Responsibilities
You will be part of the Outsourced Production team in CMC Aseptic Pilot Plant, driving project activities related to CMO productions. Your main tasks include:

  • Manufacturing activities including batch documentation.
  • Input to production facility and processes.
  • Communication with CMO before, during and after production.
  • Contribution to problem solving and handling of deviations.
  • Release process including batch review, in collaboration with QA.

Requirements
A relevant higher academic degree within pharmacy, engineering, science or similar. Experience with aseptic production of injectables and preferably with outsourcing activities. Fluent in spoken and written English. As a team player, you must be able to build relations with stakeholders and create collaboration in a global environment.

About the Department
At Aseptic Pilot Plant (APP), we are in the interface between development and production. We manufacture injectable sterile products for clinical trials. The products vary, but they are all produced according to applicable GMP requirements in an aseptic environment. Some of these products are outsourced, and we have partners globally.

Working at Novo Nordisk
We drive change and strive for excellence. We never shy away from opportunities to develop. From research and development, through to manufacturing, marketing and sales, we're working to move the needle on patient care.



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