Analytical Development Project Lead

vor 1 Monat


Darmstadt, Deutschland Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:
You take over project responsibility as an Analytical Development Project Lead and Analytical Expert in CMC teams for new chemical entities (NCE, ADC) through all clinical phases throughout the commercial launch.
- and identification techniques in-house or with external partners.

You will collaborate with interdisciplinary teams, predominantly with other internal functions of Chemical and Pharmaceutical Development and Global Pharma Operations but also with with Contract Development and Manufacturing Organizations (CDMOs). Together with regulatory functions you will issue and review regulatory documents intended for submission to Health Authorities. In close collaboration with the launch team you ensure suitability and availability of all analytical methods after transfer of know-how to commercial organizations.

**Who you are**:

- Scientific degree in pharmacy, chemistry or similar, preferably Ph.D., with an emphasis on analytical science
- Excellence in various analytical technologies and methods particularly with respect to NCE development
- Advanced knowledge in separation techniques and systematic HPLC/UHPLC method development
- +3 years of experience in the pharmaceutical industry managing analytical development project tasks
- High affinity to computerized systems
- Knowledge of current quality and international regulatory requirements for NCE and ADC development, specifically related to Quality-by-Design principles
- Very good communication skills, both written and oral in German and English
- Excellent organizational skills, reliable team player, persuasive leadership style
- High motivation towards analytical problem solving and ownership

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress



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