Scientist – Protein Characterization

Affibody is looking to recruit a Scientist in analytical chemistry/biochemistry to the Protein Characterization (PC) group. The location is in Affibody´s premises at Karolinska Institute, Campus Solna.

The PC group is scientifically and technically responsible for method development, analysis, and characterization during in-house development of Affibody candidate drugs and manufacturing processes, with a focus on projects from CD selection to late clinical phase. This includes transfer of the analytical methods to CMOs and support of analytical activities at the CMOs, e.g., method qualification/validation and stability studies. The group is accountable to obtain product knowledge to facilitate process and formulation development, e.g., through forced degradation studies, identification of degradation 
pathways and of the product´s critical quality attributes. The PC group also provides tools for control of product quality, stability, and consistency, e.g., by planning and conducting stability and comparability studies and by establishment of specifications. The work is conducted in close collaboration with CMC, Process Development, In Vitro 
Pharmacology, and other groups at Affibody working with projects in pre-clinical to late clinical phase.

The Position 
The person suitable for this position has a strong interest in analytical method development, protein characterization, and in internal and external cross functional  teamwork.

As Scientist in the Protein Characterization group, main responsibilities include: 

  • Development of analytical methods suitable for analysis and characterization of  Affibody candidate drugs in clinical development or commercial phase, e.g.,  HPLC/UPLC-UV/FLD/MS, SDS-PAGE, CE, CD and DLS methods.
  •  Biochemical/biophysical characterization of Affibody molecules.
  • Manage or support outsourcing of analytical activities.
  • Manage or support analytical method transfer to, or between, CMOs/CROs.
  • Act as analytical SME internally and in contact with CMOs/CROs regarding method  development, qualification, validation and/or protein characterization.
  • 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 during clinical development.
  • Write and review analytical documents, e.g., method descriptions, characterization  reports, protocols and reports regarding method development, qualification/validation, 
    and transfer.

Qualifications 
The right candidate fulfills the following qualificationa

  • University degree in relevant scientific discipline.
  • >2 years of experience from the biopharmaceutical industry.
  • Understanding of protein biochemistry and post-translational modifications. 
  • Experience in development of analytical methods for biopharmaceuticals during preclinical and clinical development.
  • Experience in different UPLC/HPLC techniques with emphasis on UPLC/HPLC-MS.
  • Experience in protein characterization with LC-MS, e.g. using peptide mapping and  intact MS analysis for determination of primary sequence and amino acid  modifications.
  • Experience in analytical method qualification, validation and/or transfer.
  • Experience in forced degradation, stability and/or comparability studies is a plus.
  • Experience in capillary electrophoresis, CD or DLS is a plus.
  • Excellent verbal and written communication skills in English.
  • Knowledge about regulatory requirements for analysis and characterization of  biopharmaceutical products.

Personal Attributes 
We are looking for a person with a strong scientific interest in analytical method development and protein characterization. To be successful in the role you need to have  an interest in practical laboratory work, of reading scientific publications/reports and of  sharing your results and knowledge through presentations and in reports. You are  comfortable working both independently and in internal and external cross-functional teams. You are self-motivated, driven, able to take initiatives, and results oriented with a strong sense of personal accountability. The role requires good communication and interactions skills.

More information 
At Affibody there is a local union club, an association for graduate professions [“Akademikerförening”] representing SACO, the Swedish Confederation of Professional. Associations. To get in contact with the board members of the local union, please email  AFstyrelse@affibody.se

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Datum
Upprättat: 7. februari 2024
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Förväntad start: Så snart som möjligt
Arbetsgivare
Karolinska Institute, Campus Solna
Nobels väg 5
171 65 Solna
Solna stad, Sverige