Scientist Manufacturing Product Support Specialist

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

As a leading Contract Development and Manufacturing Organization (CDMO), AGC Biologics offers unparalleled opportunities for professional growth and development. Our team of experts is dedicated to delivering the highest standard of service to our clients, working side-by-side with them every step of the way.

The ideal candidate will possess a strong academic background in science and previous experience working in a manufacturing team operating under cGMP guidelines. They should have a deep understanding of Good Manufacturing Practices (GMP) and applicable regulations, as well as experience writing, reviewing, and approving GMP documentation.

We are seeking an experienced Manufacturing Support Scientist to join our team in Copenhagen. This role requires technical problem-solving, process understanding, and inter-departmental collaboration. The successful candidate will be responsible for creating Master Production Records (MPRs) and initial production plans, reviewing MPRs, and providing training to technicians.

Responsibilities:

  • Accountable for timely deviation closure and root cause investigation
  • Responsible for batch review and enabling timely batch release
  • Participate in critical process steps and provide on-call support during batch execution
  • Capture learnings and implement continuous improvements to processes

Requirements:

  • Masters degree in Engineering or Protein Science-related field
  • Experience in upstream or downstream operations, preferably in clinical/commercial GMP manufacturing
  • Demonstrated understanding of GMP and applicable regulations
  • Strong communication and presentation skills


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