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.

Principal Scientist CMC Analytical Development (all genders) 

As a Principal Scientist in Analytical Development, you will lead analytical projects focusing onr drug products from early clinical studies to launch, ensuring the compliance of our development products with ICH guidelines and GMP standards. You will drive complex projects, work in multidisciplinary teams, and provide expertise for strategic studies and regulatory submissions. We are looking for a research-driven professional with a deep passion for analytics, team leadership, and innovative processes. 

YOUR TASKS AND RESPONSIBILITIES 

• You will be responsible for all analytical project activities for the development of drug products (including cleaning verification) according to the project milestones and represent analytical development in multidisciplinary CMC-Teams
• As a subject matter expert (SME), you will provide technical and scientific guidance, develop and validate state-of-the art analytical methods for characterization of development products, plan experiments, define specifications and test procedures, evaluate analytical data, and prepare analytical reports (e.g. method validation, stability studies)
• You will transfer analytical methods to external partners and commercial quality control
• You will prepare and review registration documents and respond to regulatory inquiries
• You will lead diverse analytical project teams, handle multiple technologies, coordinate activities with external suppliers/contract laboratories, and ensure GMP compliance of all project-related activities
• You will smoothly collaborate with internal and external stakeholders (e.g. chemical development, oral and parenteral drug development, quality control, CROs/CDMOs) and will be a close partner for formulation development
• You will actively contribute to the ongoing development of your Home Cluster CMC Analytics, promoting innovation and efficiency in analytical activities
• You will mentor and train Analytical Development Specialists and Scientists and provide professional guidance to doctoral candidates and postdocs while role-modeling VACC leadership principless

WHO YOU ARE 

• You hold an advanced degree (Ph.D. or equivalent) in Analytical Chemistry, (Bio)Chemistry, Pharmaceutical Sciences, or a related field
• You have solid professional experience with analytical drug product focus in the pharmaceutical industry, particularly in analytical development or Quality Control of new chemical entities; first experiences in cleaning verification are an advantage
• You are proficient in instrumental analysis, particularly HPLC, and LC-MS, and have a good understanding of drug product analytics and modern analytical method development (ICH Q14)
• You have strong knowledge of regulatory requirements and quality standards (ICH, GMP), especially regarding approval of development drugs
• You work in a structured, problem-solving way, efficiently handling complex projects, and embrace challenges proactively
• You challenge the status quo constructively, bring innovative ideas, and drive them to results
• You communicate effectively in German and English, both written and spoken, and enjoy working collaboratively in interdisciplinary teams  

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 through a competitive compensation package, consisting of an attractive base pay and our annual bonus. In addition, managers can recognize special contributions by granting an individual performance award or top performance award.
• Whether it’s hybrid work models or part-time arrangements: Whenever it is possible, you will have the flexibility to work how, when and where it is best for you.
• 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 embrace 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 race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
 

Location:           ​​ ​   Berlin​

​​Division: ​               Pharmaceuticals​

Reference Code:  861373​