Senior Scientist, Quality Control Specialist

4 days ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Job Overview

The QC Raw Material team at AGC Biologics is seeking a highly skilled Senior/Principal Scientist to support the implementation of new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.

Main Responsibilities

  • Develop and review raw material specifications based on European or US regulatory guidelines and adapt to supplier change notifications.
  • Deliver scientifically sound and cGMP compliant raw material documents and analytical results.
  • Promote risk assessments and create qualification protocols/reports for the raw material program.
  • Oversight of sampling, both internal and outsourced testing.

Key Requirements

  • MSc or PhD degree in Chemistry, Pharmaceutical Sciences, or relevant area.
  • Work experience within quality control or quality assurance.
  • Profound writing and reviewing skills for cGMP documents.
  • In-depth understanding of US and European pharmacopoeias.
  • Experience handling change controls, deviations, and CAPAs.
  • Ability to work independently and as part of a high-paced team.
  • Business understanding and contract manufacturing experience.
  • Audit and inspection representation.


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