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.

Tasks & Responsibilities:

• 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.
• Experience with biochemical analytical techniques and antibody biochemistry, binding assays, functional cell-based assays, PCR.
• And/or: Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization techniques
• Experience with PAT (Process Analytical Technologies), spectroscopy and/or biopharmaceutical manufacturing processes is a plus
• 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, communication skills in German is a plus.
• Strong team player, demonstrating mutual respect.

Sounds interesting? Apply now – we’re looking forward to receiving your applications!