Senior Principal Scientist (all genders) - External API Development for New Chemical Entities

You are an experienced synthetic and process chemist with the ambition to shape the chemical foundation of our R&D pipeline for new chemical entities (NCEs) by designing, developing, and enabling synthetic routes that evolve into robust API manufacturing processes in partnership with our external CDMO network.

In this Drug Substance (DS) Lead position within global CMC teams, you define and drive the DS strategy and are accountable for the DS contribution to the overall CMC package. Serving as the central interface between internal stakeholders and external partners, you lead chemical process development and API supply activities, enabling phase-appropriate, scalable, and sustainable manufacturing processes that ensure timely API delivery, robust product quality, and cost efficiency.

### **YOUR TASKS AND RESPONSIBILITIES**

• 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

### **WHO YOU ARE**

• 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

### **WHAT WE OFFER**

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: **What matters to you, matters to us!**

• We ensure your **financial stability** with a competitive salary between 109.800€ and 138.500€ per year (full-time) plus a variable component and a global equity-based cash plan. Your compensation is based on your qualifications, skills, and professional experience.
• **Your family** is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more.
• We support your **professional growth** by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs.
• We promote **health awareness** and opportunities for selfcare through various measures, such as free health checks with the company doctor.
• We emb diversity by providing an **inclusive work environment** in which you are welcomed, supported, and encouraged to bring your whole self to work.

Be You. Be Bayer.

#LI-AMSEMEA

• *YOUR APPLICATION**

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Bayer welcomes applications from all individuals, regardless of , national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, , orientation, gender identity, gender expression or any criterion under applicable law. We are committed to treating all applicants fairly and avoiding .

• *Location:** ​​ ​   Germany : North Rhine Westfalia : Wuppertal-Elberfeld || Germany : Berlin : Berlin​

​​**Division:** ​               Pharmaceuticals​

• *Reference Code:** 878474​

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Quelle: Statistisches Bundesamt (Destatis), Tabelle; dl-de/by-2-0; eigene Berechnung