Senior Expert - Munich, Deutschland - Sandoz

Sandoz
Sandoz
Geprüftes Unternehmen
Munich, Deutschland

vor 4 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

Job ID BR- Aug 02, 2023- Germany
Job Description:

  • 2023 will potentially see Sandoz become a standalone organization Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally
  • Together we will shape the future of Sandozare you ready to make a difference?
  • 600 million that's how many people suffer from asthma and COPD worldwide. Many of the innovative medicines are expensive. Sandoz is working hard to offer affordable generics for respiratory diseases.
  • The role is part of Biopharma Technical Development and will be based in Holzkirchen, Germany. Our Analytical Characterization Department applies a wide range of analytical methods and interesting strategic decisions in order to investigate physicochemical properties of our biosimilar products and to support biosimilar development from early stage until market entry. You will be supporting the characterization of DS / DP through various project phases from clone selection to process characterization, method transfers, comparability studies, similarity and submission. Center of all our activities is the cooperation of all team members and the contribution of each individual.

Your key responsibilities:


Your responsibilities include, but not limited to:

  • Independently lead/manage mass spectrometric related project activities and contribute to technical discussions and investigations within the analytical group in order to support project-related strategic decisions. Interpret results, evaluate data, and draw relevant conclusions; ensure integrity of data; review and approve raw data generated by others.
  • Design and execute mass spectrometry assays (e.g. ESI-MS, MALDI-MS, ion mobility MS, CE-MS etc. for intact and peptide mapping analysis); coordinate qualification and tech transfer of developed methods. Contribute to implementation of new technologies for characterization of biosimilars (e.g. IgGs, ADCs, etc).
  • Author development reports, study protocols, SOPs, qualification/prevalidation reports and analytical assay tech transfer documents

In particular:

drafting individual chapters of regulatory documents and interacting directly with authorities as appropriate in topics related to mass spectrometry.

Act as a technical expert in audits and inspections as needed.

  • Provide scientific and technical guidance; perform information and literature searches; actively drive knowledge exchange. Train and coach other scientific associates; present scientific/technical results internally and externally, contribute to publications, presentations and patents.
  • Ensure good documentation practices.

Diversity & Inclusion / EEO:


  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum Requirements:


What you'll bring to the role:

  • Minimum: Degree with ideally PhD in Bioanalytical, Chemistry or other natural sciences and with 2 years of relevant experience in the biopharmaceutical industry; or Master of Science with 6 years / Bachelor of Science or equivalent technical education with 12 years relevant experience in the area of mass spectrometry.
  • Excellent knowledge in analytical characterization of biopharmaceutical products (proteins, peptides, oligonucleotides, etc.) using mass spectrometry and ideally experienced on characterization of ADCs and/or N/Oglycoproteins.
  • Excellent knowledge of relevant MS and chromatography software and computer tools. Ideally experience working with Chromeleon and Refiner MS.
  • Excellent communication and presentation skills; willingness to work in interdisciplinary, international teams, strong record of creativity, problem solving and productivity in projects.
  • Business fluent language skills in English
  • The job will be based in Holzkirchen and requires to be present on site (in the lab) for most of the days.

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.


  • How will we do this? We believe new insights, perspectives and groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
  • We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying**Imagine what
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