Master student Analytical Characterization (temporary for 6 months)

Sandoz continues to go through an exciting and transformative period as a

global leader and pioneering provider of sustainable Biosimilar and Generic

medicines. As we continue down this new and ambitious path, unique

opportunities will present themselves, both professionally and personally. Join

us, the future is ours to shape!

Master Student Analytical Characterization (d/f/m) temporary for 6 months

Master thesis with the topic:

Development of a robust reducing peptide mapping workflow to characterize mAb via multi-attribute method (MAM)

The multi-attribute-method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based method that is used to comprehensively characterize and monitor numerous critical quality attributes (CQAs) at the amino acid level of a biopharmaceuticals. The MAM is based on the reduced peptide mapping (rPepmap) workflow, encompassing the in-solution disulfide linkage reduction and alkylation, proteolytic digestion of proteins into peptides followed by reversed-phase LC separation and MS detection and identification. To develop a reliable MAM, an optimized rPepmap workflow needs to be implemented to increase the robustness and the reproducibility of LC-MS data for identification and relative quantification of CQAs.

This research work mainly focuses on:

• Optimization of sample preparation for protein digestion to reduce methionine related method artefacts, and to reduce the efforts for the regeneration of column, as well as to reduce the misscleaved or nonspecific cleaved peptide abundance and to increase the overall protein sequence coverage. Additionally, test of SP3 magnetic beads-based method for protein digestion and buffer exchange
• Optimization of MS and MS/MS acquisition parameters to enhance the peptide fragmentation and identification, as well as the relative quantification of post-translational modifications (PTMs)
• Perform a method feasibility study to assess robustness and reproducibility of the optimized workflow according to the ICH Q2(R2) guidelines, including (but not limited to): sensitivity, reproducibility, accuracy, specificity, and robustness
• Apply the established LC-MS workflow to characterize the model protein (mAb and its variants or impurities, e.g. host-cell proteins), both qualitatively and quantitatively.

The optimization will be based on an existing rPepmap workflow using 1-2 mAbs as model proteins. Samples will be measured on a Vanquish UPLC or nanoLC coupled to a Fusion Orbitrap MS system with the capability of performing high-energy collisional dissociation (HCD) and electron transfer dissociation (ETD).

Eligibility requirements:

• Postgraduate in analytical chemistry, chemical biology, biochemistry or related fields.
• Theoretical knowledge of mass spectrometry is essential, practical experience in mass spectrometry, instrumental analysis and/or protein (bio-)chemical analysis is of advantage
• Very good knowledge of the English language, both spoken and written
• Flexible, committed and self-organized working style is required

We offer a modern, equipped laboratory, cooperative research work in an interdisciplinary setting and international team as well as comprehensive support.

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. The first to develop an oral penicillin antibiotic. The first to develop and launch biosimilars. The first to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous, and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Join us, and help reimagine access to medicine.

Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.