Senior Principal Scientist - External API Development for New Chemical Entities (m/f/d)

Your Profile:

• Ph.D. in Chemistry or a related science, with extensive experience in the pharmaceutical industry, including an understanding of GLP/GMP and regulatory expectations
  
• Strong background in synthetic chemistry, with an excellent understanding of reagents, methodologies, and reaction mechanisms, plus a solid grasp of analytical techniques
  
• Experience in the CMC development of peptides is a plus
  
• Experience in steering external partners (CROs/CDMOs) or working across an external manufacturing network is a clear advantage
  
• Proven ability to represent chemistry and Drug Substance in interdisciplinary CMC or project teams and to act as an accountable interface between the internal organization and external partners
  
• A strategic thinker with the ability to think innovatively, develop and analyze multiple solutions to complex chemistry problems, and challenge the status quo
  
• Strong communication and project management skills across scientific disciplines, cultures, and organizational boundaries, combined with assertiveness, service orientation, and enjoyment of cross-functional teamwork
  
• Fluency in English (negotiation level), both written and spoken; German is an asset and willingness to learn German is required

Your Tasks:

• Provide scientific leadership for the design, assessment, and optimization of synthetic routes for new APIs in preclinical and clinical phases, with a focus on speed, quality, cost, sustainability, and process understanding
  
• Represent Drug Substance (DS) in global CMC development project teams and contribute to key scientific, strategic, and portfolio decisions, while ensuring a coherent two-way flow of strategy, decisions, risks, and progress between the internal global CMC team and external CDMO activities
  
• Guide and challenge route design and synthetic methodology choices at external CDMOs, translating SAR-driven chemistry into scalable routes for preclinical and clinical supply and future production in alignment with the internal DS development strategy
  
• Oversee external API campaigns for toxicology studies and clinical trials, including planning, risk assessment, supply-demand alignment, and budget oversight
  
• Steer process transfers between external partners and into internal development or external manufacturing, ensuring knowledge continuity and phase-appropriate documentation
  
• Contribute to robust, phase-appropriate control strategies. Co-author and review the Drug Substance sections of regulatory filings (IND/IMPD and briefing documents) and support responses to health authority questions
  
• Provide CMC DS assessments for in-licensing opportunities
  
• Provide chemical expertise and pragmatic troubleshooting across the internal and external manufacturing network. Actively contribute to the chemistry community by sharing knowledge and driving innovation across organizational boundaries

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