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Senior Scientist/Scientist Protein Characterization

Affibody is looking to recruit a Senior Scientist/Scientist to the Protein Characterization group. The location is in Affibody’s premises at Karolinska Institute Campus Solna.
Upprättad
Ansökningsfrist
den 15 december 2021
Förväntad start.
Så snart som möjligt
Anställningsförhållanden
Fast
Antal timmar
Fulltid
Anställning
Fast
Region
Sverige > Stockholms län > Solna stad

The Protein Characterization group is scientifically and technically responsible for method development, non-GMP analysis and characterization of our biomolecules during in-house development of candidate drugs, process development and manufacturing. The group is also responsible for outsourcing certain activities concerning analytical method development and characterization. The Protein Characterization group is further responsible for strategies and oversight of method development, sourcing and managing external analysis of Drug Substance and Drug Product for Affibody’s projects in clinical and commercial development. The work is conducted in close collaboration with the CMC group and other relevant groups at Affibody that are involved in manufacturing.

The role in general
The person suitable for this role has a strong interest in analytical method development and protein characterization, in keeping up to date with the development of the field within the industry, and in internal or external cross functional team work.

As Senior Scientist/Scientist in the Protein Characterization group your main responsibilities include:

  • Development of analytical methods (e.g. HPLC/UPLC techniques, LC-MS, SDS-PAGE, CD, DLS) for biopharmaceuticals in clinical and commercial development
  • Characterization of Affibody® candidate drugs
  • Lead analytical in-house activities, e.g. forced degradation studies
  • Outsource and manage analytical activities at CMOs/CLOs, e.g. method development, analysis and characterization
  • Manage or provide scientific expertise in tech transfers of analytical methods, comparability and stability studies
  • Scientific expert in qualification and validations of analytical methods
  • Provide analytical expertise in formulation development
  • Perform analytical and characterization matters in deviation investigations, CAPA and change control
  • Be up to date regarding method and technology development within the field
  • Be up to date regarding regulatory requirements for analysis and characterization of biopharmaceutical products
  • Write and/or review analytical documents, e.g. method descriptions, protocols and reports regarding method qualification, validation and transfer, and applicable sections in registration files and variations

Qualifications
The right candidate fulfills the following qualifications:

  • University degree in Life Sciences
  • A minimum of 10 years of experience of the pharmaceutical industry
  • Experience and deep knowledge of analytical method development and characterization of biopharmaceuticals during clinical and/or commercial development
  • Experience of analytical method qualification/validation and transfer
  • Experience and knowledge of forced degradation and comparability studies
  • Experience of leading/coordinating analytical activities (in-house and out-sourced)
  • Knowledge about regulatory requirements for analysis and characterization of biopharmaceutical products
  • Excellent verbal and written communication skills in English and ability to communicate in a business environment

Personal attributes
We are looking for a person with a strong scientific interest in analytical method development and protein characterization, who is well up to date with the development of the field within the industry as well as with relevant regulatory guidelines. To be successful in the role you need to be highly self-motivated and driven. You need to be comfortable working in a dynamic environment in a growing organization and in cross-functional teams, with strong team working skills to establish and maintain good collaboration with different parties, both external and internal. You have capabilities to analyze complex information or situations and provide sound solutions and to identify, adapt and implement new technologies. You also need to have the capability to prioritize activities in order to deliver business critical goals in time.

 

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Application
We will interview candidates continuously and welcome your application today!

Please send your application (CV and a note on why you think this is your next step) to hr@affibody.se. If you have any questions about the role, please contact Head of Protein Characterization, Maria Wrangel, at Maria.Wrangel@affibody.se.



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Affibody AB

Affibody AB

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