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The integrated Biologics Analytical Department provides support to the Biotechnology Department by performing release and stability testing of biological drug substances and is supporting global outsourcing of analytics for biologics, followed by study and quality monitoring to guarantee adherence to regulatory requirements and internal guidelines. Furthermore, the department conducts raw-/starting material and in-process testing for biological drug substances.
Job Responsibility:
Execution of analytical testing of drug substance release, stability and characterization for biologics under GMP/GDP
Support of analytical method validation and transfers, write technical protocols and report
Troubleshoot methods to ensure seamless method qualification & execution in the laboratory
Support equipment maintenance, calibration and qualification & periodic review
Works in accordance with applicable internal company regulations: safety, health and environmental protection
Improvement of methods and troubleshooting around equipment and procedures
Release and stability testing of biologics to determine relative potency according to cGMPs
Documentation of activities in an electronic laboratory notebook according to cGMPs
Supporting equipment maintenance and calibration activities
Requirements:
Education as a laboratory technician EFZ or a scientific bachelor’s degree
Work experience in a GMP laboratory
Ability to communicate and document in English
Strong team player, demonstrating mutual respect
Nice to have:
Communication skills in German
Experience with PAT (Process Analytical Technologies), spectroscopy and/or biopharmaceutical manufacturing processes