Senior Expert R&D Developability and Formulation (m/f/d)

Your Profile:

• PhD or MSc in Pharmaceutical Sciences, Biochemistry, Chemistry, or related field, with proven industry experience in biologics formulation development
  
• Proven track record of advancing protein formulations through clinical development, ideally including late-stage or commercial products
  
• Strong expertise in parenteral formulations, including formulation design and excipient selection
  
• Experience in development subcutaneous drug product and lyophilization development is a strong plus
  
• Solid background in data-driven formulation development, applying DoE and QbD principles, with hands-on experience in biophysical and analytical characterization
  
• Sound understanding of ICH/GMP requirements and experience preparing CMC documentation for regulatory submissions (e.g., IND, CTA, BLA/MAA)
  
• Strong ability to drive scientific decisions, collaborate effectively in cross-functional teams (e.g., Analytics, Pilot Production, CMC/Regulatory stakeholders), and operate in a dynamic R&D environment
  
• Experience in advanced drug delivery approaches (e.g., oral delivery, sustained-release systems) is considered a plus

Your Tasks:

• Develop and define formulation strategies for protein drug candidates across all development stages, including stability assessment, excipient selection, and container-closure compatibility
  
• Lead formulation development programs, taking strong scientific ownership and coordinating external partners (e.g., CROs and CDMOs), while ensuring cross-functional alignment and data-driven decisions
  
• Plan, design, conduct, and critically review complex experimental studies, integrating advanced and risk-based approaches (e.g., DoE, QbD, stability modeling)
  
• Support scale-up and technology transfer to clinical manufacturing, ensuring robust translation into GMP production with internal teams and external partners
  
• Playing a leading role in CMC activities, including authoring, reviewing, and shaping documentation for regulatory submissions
  
• Drive innovation by leveraging scalable approaches, device and packaging solutions, and emerging technologies
  
• Mentor colleagues and contribute to scientific excellence, knowledge sharing, and continuous improvement
  
• Actively contribute to the department's scientific goals, innovation efforts, and cross-functional discussions, with a proactive and collaborative mindset

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