Stellenbeschreibung

CSL Behring – the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.

For our location in Bern, for the Impurity and Data Management team within Technical Operations R&D department we are looking for a

Scientist in Technical Operations, R&D (100%)

Main Responsibilities and Accountabilities:

• Planning, coordination and reporting of impurity profile and impurity-based comparability studies performed in the course of validation purpose for:
  
  
  
  • Process changes and transfers for all licensed CSL Bern products.
  
  
  • New products or processes.
  
  

• Support updates of registration dossiers and inquiries from authorities:
  
  
  
  • Compile and update impurity characterization sections of registration dossiers.
  
  
  • Compile answers to inquiries from authorities related to impurity characterization of submitted and licensed Bern CSL products.
  
  

• Support quality investigations with respect to impurity characterization:
  
  
  
  • Planning, coordination and reporting of impurity analyses for deviations and process changes of licensed Bern CSL products.
  
  
  • Perform statistical evaluation of analytical data related to task force activities, initiative activities.
  
  

• Support commercial and production with technical and scientific expertise on CSL processes and products.


• Maintenance and optimization of Technical Operations analytical databases (impurity database, product specific database).


• Representative of Operations Support in LCM projects, development projects, task forces, initiatives, quality boards.

Qualifications & Experience:

• University of life sciences: Master or PhD in Biochemistry, Biology, or in a related field.


• Practical experience and good knowledge in relevant fields in particular plasma proteins and purification of proteins.


• Competent to plan, evaluate, interpret and report scientific and experimental data.


• Ability to address autonomously scientific questions.


• Team player with good verbal and writing communication capabilities and ability to work in interdisciplinary teams.


• Expertise in statistical evaluation of analytical data and knowledge in specific statistical tools (i.e Statistica, Minitab, R) would be an advantage.


• Fluent written and spoken German and English.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.