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The department 'Analytical Development and Quality Control Biotech Europe' is responsible for Biochemical Analytical Development, Quality Control and Compliance required for Analytics of Biopharmaceuticals from pre IND (Investigational New Drug) to NDA BLA (New Drug Biologics License Application) and Launch.

With the main responsibility for development, improvement and validation of analytical methods for the quality assessment of active substances and galenical forms, the Senior Associate Analytical Development Biochemistry is also responsible for:

Analytical measurements by mass spectrometry for Drug Products including multi-attribute approaches

Characterization and quantification by mass spectrometry of formulation components and their degradants

Quality control for investigational medicinal products and batches used in preclinical studies

Together with the other group members, planning and monitoring of the work packages to ensure efficient analytics and continuous improvement

Maintaining efficient and timely GxP-conform analytics and documentation following the current GxP guidelines as well as the relevant SOPs

In addition, the Senior Associate Analytical Development Biochemistry is also responsible for:

Independent implementation of mass spectrometry projects for the evaluation of biomolecules in close cooperation with the Working groups on site

Characterization and quantification of modifications in enzymatic Peptide Mapping of biomolecules and of small molecules in formulation samples

Developing and optimizing of methods various issues

Evaluating, implementing and further developing new analytical technologies and methods for protein as well as excipient analytics

Planning and monitoring of the work packages to ensure efficient analytics together with the other group members, and continuous improvement

For this interesting challenge, you bring the following qualification:

Education and Experience: Bachelor's degree in analytics, biochemistry, biotechnology, or a similar scientific field, such as a lab apprenticeship (Laborausbildung). You should have 1-3 years of experience in the biopharmaceutical industry, with a strong focus on analytics, preferably in a GMP environment.

Mass Spectrometry and HPLC: Experience with mass spectrometry is required. Hands-on experience with HPLC separation techniques for biomolecules (e.g., RPC, SEC) is mandatory.

Sample Preparation and Instrument Skills: You need profound knowledge of sample preparation strategies for protein and peptide samples for mass spectrometry analysis. Skills in operating and maintaining modern MS and LC-MS/MS systems are a plus. Experience in the biopharmaceutical industry with a strong focus on analytics, and specific knowledge of automated sample preparation and GMP, are an advantage.

Personal Attributes: You should be highly self-motivated, proactive, and an excellent team player with a results-oriented mindset. You should also have enthusiasm for complex instruments, technical challenges.

Language Skills: Fluent German and English language skills are required, both written and spoken.

To apply for this position, please submit a complete application, including the following documents: Curriculum Vitae, Cover Letter, Reference Letters and Academic Transcripts or Study Certificates

This is a two-year temporary position.

We look forward to your application!

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