Major accountabilities:

· Conduct and coordinate quality control tests on biologics drug substances (Physicochemical testing, e.g. HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements

· Independent planning, implementation, and evaluation of routine and special analyses in a GMP-regulated environment

· Interpret test data, prepare detailed reports, and maintain accurate record of test results.

· Troubleshoot testing procedures and make recommendations for improvements, with a focus on HPLC and Capillary Electrophoresis

· Conducting microbiological tests such as total germ count determinations (MET) and bacterial endotoxins (BET)

· Participate in the validation of analytical procedures

· Collaborate closely with the internal teams to optimize quality control processes

· Instrument responsibilities, including qualification, maintenance, and calibration documentation

· Support in ensuring that the laboratory is maintained in a ready state of inspection.

Key performance indicators:

· Timely test record completion and accurate processing without delays

· Prompt reporting of missed deadlines and aim for shortest possible lead times

· Continuous readiness for inspection

· Consistently follow the GMP and GSU guidelines, and SOPs, ensuring no critical irregularities

· Proactively identify and implement cost-reducing optimizations

· Complete all assigned training as per the provided plan

Minimum Requirements:

· Completed scientific education (e.g., Laboratory Technician, Bachelor or Master)

· Practical experience in a GMP-regulated lab and document creation

· Knowledge in common analysis techniques, especially HPLC and photometry; microbiological knowledge is an advantage

· Working experience in laboratory environment in the pharmaceutical industry

· Good IT skills (MS Office) and laboratory software like LIMS, Chromeleon, Empower are an advantage

· Ability to work precisely, independently, and proactively

· Reliability, flexibility, resilience, and strong teamwork skills

· Shift work with normal working times (one shift) including weekends

Skills:

· Continuous learning

· Dealing with ambiguity

· Decision making

· GMP

· Industry standards

· Laboratory equipment

· Laboratory excellence

· Quality Control (QC) testing

· Quality Control sampling

· Self awareness

· Technological expertise

Languages :

· Fluent in German (spoken and written) and proficient in English

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