Drug Substance Expert

vor 2 Wochen

Aubonne, Schweiz Merck KGaA 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**:The purpose of this position is to lead the MSAT network for Drug Substance with a focus on upstream & cell culture media. As a Drug Substance Expert, you will provide technical leadership for drug substance manufacturing operations, tech transfer activities, and technical life cycle management projects. Your responsibilities include directing cross functional projects, implementing initiatives for continuous improvement in manufacturing capabilities, and facilitating knowledge sharing and best practices. You will also collaborate on cross-functional and cross-site technical projects related to drug substance manufacturing, develop strategies for scale-down and characterization of existing manufacturing processes, and lead innovation efforts. Additionally, you will support troubleshooting, product impact assessments, and process/product improvement activities within the DS manufacturing network. You will review technical reports, validation documents, and regulatory submissions, and represent the company in drug substance-related industry consortiums.

**Who you are**:

- You hold a degree in Life Science/Engineering, preferably with a Ph.D., and have at least 10 years of experience in the pharmaceutical industry.
- You possess 5+ years of expertise in biologics drug substance process development or manufacturing, with a focus on upstream/cell culture processes.
- You have strong technical knowledge of biologics drug substance manufacturing, particularly in cell banking and upstream processing (fed-batch & perfusion).
- You have a deep understanding of relevant regulatory guidelines, cGMP, and validation practices.
- You have a proven track record of building and leading teams of highly qualified engineers and scientists in a matrix environment, spanning development and (clinical) manufacturing of biologics.
- You demonstrate the ability to collaborate, negotiate solutions, and interact with different functions and stakeholders within the organization.
- You have strong analytical and problem-solving skills to support and improve production capabilities.
- You are proficient in English, and knowledge of German, French, or Italian is considered a plus. Moderate travel requirements of approximately 10-20% of your time are expected.

**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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