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

Bayer AG Pharmaceuticals; Berlin; Vor Ort; EUR 110.000 - 139.000; Vollzeit

Benefits dieser Stelle

Company daycare centers

Learning and development opportunities

Health checks and wellbeing programs

Diversity and inclusive environment

Zusammenfassung

Bayer AG Pharmaceuticals in Germany seeks a Senior Principal Scientist to lead external API development for new chemical entities. You will guide route design, assess external CDMOs, and ensure alignment with internal DS strategy across preclinical and clinical stages.

The role requires a Ph.D. in Chemistry, GMP/GLP awareness, and strong collaboration across multidisciplinary teams, including regulatory affairs and external partners.

Qualifikationen

• Ph.D. in Chemistry or related science with GLP/GMP and regulatory understanding.
• Strong background in synthetic chemistry and analytical techniques.
• Experience coordinating with CROs/CDMOs and external partners is a clear advantage.

Aufgaben

• Provide scientific leadership for design, assessment and optimization of routes for new APIs.
• Represent Drug Substance in global CMC teams and guide external partnerships.
• Steer route design with external CDMOs and translate SAR-driven chemistry to scalable routes.
• Oversee external API campaigns for toxicology and clinical studies, planning and budgets.
• Contribute to transfer of processes between external partners and internal or external manufacturing.
• Assist with regulatory filings (IND/IMPD) and responses to health authority questions.

Kenntnisse

Strategic thinking

Project management

Strong communication

Cross-functional collaboration

Ausbildung

Ph.D. in Chemistry

Tools

Regulatory documentation handling

Jobbeschreibung

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility.

We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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

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

• We ensure yourfinancial 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 yourprofessional 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 promotehealth awareness and opportunities for selfcare through various measures, such as free health checks with the company doctor.
• We emb diversity by providing aninclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.

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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