27 ago
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Merck Group
|
Guidonia Montecelio
27 ago
Merck Group
Guidonia Montecelio
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 “Global Analytical and Pharmaceutical Scientific Innovation” Department / “Analytical Regulatory and CMC Science” Unit is providing Regulatory support and coordination on analytical topics (HAs queries, renewal, compliance GAPs), including improvement in pharmacopoeial compliance, and support improvement in the quality of the analytical documentation for biological products (mAbs, recombinant proteins, fusion proteins, ADCs).
It is also proactively monitoring new analytical requirements by Regulatory Authorities and cross check discrepancies among different pharmacopoeial requirements, ensuring that methods, technologies, and validation are compliant/aligned to latest regulatory expectation. Finally, it is providing Scientific support through matrix interaction with different Functions (including BR-CMC, R&D;, MBQ). **Who you are**: - Degree in Life Science is required (Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Chemistry, or equivalent)
- Several years of experience in senior roles of analytical development and validation.
- Strong knowledge of regulatory requirements.
- An experience in physico-chemical characterization method is a plus
- Demonstrated ability to collaborate and negotiate solutions in a matrix environment and interacting with different functions/stakeholders in the organization
- Problem solving skills
- Excellent skills in writing, oral, interpersonal communication, and presentation (English) This posting will expire in 2 weeks. **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!
📌 Advanced Scientist L. 68/99 (Guidonia Montecelio)
🏢 Merck Group
📍 Guidonia Montecelio