Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D (Biologics)

Location: Ludwigshafen, Germany

Company

hirify.global develops innovative medicines and healthcare solutions across areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead and mentor scientists working on separation-based assays, including HPLC and capillary electrophoresis, for biologics sample testing.
• Support biologics process development, characterization, validation, GMP manufacturing investigations, and early-stage clinical programs.
• Act as the analytical representative and subject matter expert in cross-functional CMC teams.
• Develop, execute, troubleshoot, validate, transfer, and maintain analytical test methods, including batch release activities.
• Evaluate analytical technologies, support automation and high-throughput methods, and implement novel techniques to improve robustness.
• Communicate project data, risks, and issues while guiding analytical strategy, technical development, and project delivery.

Requirements

• PhD in chemistry, biology, biochemistry, chemical engineering, or a related technical discipline.
• At least 8 years of professional experience in a biotechnology or pharmaceutical environment.
• Experience leading analytical development and quality control activities for biologics, including monoclonal antibodies, multispecifics, antibody-drug conjugates, and fusion proteins.
• Expertise in protein and impurity analysis techniques, including HPLC and capillary electrophoresis.
• Experience with technical writing and documents with regulatory impact.
• Strong people leadership, communication, troubleshooting, problem-solving, and cross-functional collaboration skills.

Nice to have

• Experience as Head of Quality Control under 12 AMWHV.
• Experience with mass spectrometry and ELISA.

Culture & Benefits

• Diverse and inclusive work environment with an open corporate culture.
• Flexible work models supporting work-life balance.
• Comprehensive corporate health and exercise programs.
• Company social benefits and extensive career development opportunities.
• Mentored onboarding and access to an international professional network.

Hiring process

• Submit a complete CV.
• Further details are discussed during the application process.