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Quality Control Specialist

1 week ago

Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time
Job Description

As a Senior Chemistry Scientist, you will be part of a dynamic team that supports the development and implementation of analytical methods for the biologics Drug Substance (DS) production and global release of commercial products (DS/Drug Product).

Key Responsibilities:

  • Implementing and supporting multiple chemistry methods for technology transfer programs
  • Working closely with QC testing teams and contract laboratory organizations to ensure timely implementation of new analytical test methods for release testing
  • Authoring and reviewing qualification and transfer/validation protocols, reports, and SOPs
  • Supporting the implementation and setup of new instruments
  • Method troubleshooting, data analysis, and data evaluation

Requirements:

  • Master of Science within Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, Protein Chemistry, or Biology
  • Minimum 5 years of experience from the biotech or pharmaceutical industry or university
  • Broad background in analytical methods, such as icIEF, CE-SDS, and U/HPLC
  • Experience in the Unites States Pharmacopoeia and the European Pharmacopoeia
  • Knowledge of ICH guidelines are an advantage, but not a requirement

Benefits:

  • A competitive salary package
  • Opportunities for professional growth and development
  • A collaborative and dynamic work environment
  • Access to cutting-edge technology and equipment