CMC Analytical Scientist/Project Lead for New Chemical Entities (all genders)

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.

CMC Analytical Scientist/Project Lead for New Chemical Entities (all genders)

Join our team as a CMC Analytical Project Lead and take a key role in shaping the analytical development of innovative new chemical entities. You will lead cross-functional teams and analytical strategies for active pharmaceutical ingredients, ensuring scientific excellence and regulatory compliance at every stage of development.

YOUR TASKS AND RESPONSIBILITES

• You lead analytical project activities for new chemical entities with a focus on active pharmaceutical ingredients from (pre-)clinical phases to market, including new modalities (e.g. targeted radiopharmaceuticals), ensuring alignment with project timelines and regulatory requirements
• You represent analytical development in CMC technical development teams
• Considering the requirements of relevant guidelines such as ICH Q11 and ICH Q14, you develop and implement robust control strategies as well as analytical methods for APIs, raw materials, intermediates and starting materials
• You oversee and lead analytical development activities such as planning experiments, generating data and writing the corresponding analytical reports (e.g. for specifications, validation of analytical methods, stability studies, physical and chemical characterization of APIs, reference standard characterization)
• You prepare and review registration documents and responses to regulatory inquiries
• While ensuring an adequate GMP status for all project-related activities, you lead diverse analytical project teams working with different analytical technologies, focusing on chromatographic and mass spectrometric techniques
• You collaborate with internal and external stakeholders (e.g. Chemical Development, NBE Analytics, arm’s lengths companies) and lead outsourced analytical activities at CROs/CDMOs for your projects
• You actively contribute to the ongoing development of our organization,  promoting innovation and efficiency in analytical activities
• You exemplify leadership by guiding teams toward mission-driven outcomes, designing systems that inspire and empower people removing barriers to enable collaboration and developing team capabilities through ongoing support and learning

WHO YOU ARE

• You have an advanced degree (Ph.D. or equivalent) in analytical chemistry, (bio)chemistry, pharmaceutical sciences, or a related field
• You have proven professional experience in CMC development within the pharmaceutical industry, particularly in analytical development of new chemical entities
• You bring proficiency in instrumental analysis (particularly HPLC, GC, MS, LC-MS)
• You have good knowledge of organic/medicinal chemistry and biochemistry
• It is an advantage if you have strong knowledge of regulatory requirements and quality standards (e.g. ICH, GMP), especially regarding market approval of new drugs
• You have experience with modern concepts in analytical method development (ICH Q14) and risk evaluation of pharmaceutical development drugs (ICH Guidelines Q8 to Q11)
• Extensive leadership, communication and project management skills set you apart
• Very good written and spoken German and English skills round off your profile

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, our performance based company bonus and a global, equity-based cash plan with a four-year duration. In addition, managers can recognize special contributions by granting an individual 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 support your health and well-being with free check-ups by our company doctor, health seminars, and a wide range of initiatives that promote a healthy lifestyle.​
• We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.​
  
  

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: ​ ​ ​ Germany : North Rhine Westfalia : Wuppertal-Aprath || Germany : North Rhine Westfalia : Wuppertal-Elberfeld ​

​ ​ Division: ​ Pharmaceuticals ​

Reference Code: 846520 ​