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Senior Scientist, Functional Biocharacterization and Impurities
- General Summary_:
Just Evotec Biologics EU is seeking a motivated and creative Senior Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics.
- Missions and responsibilities_:
- Development & Qualification of biological functional analytical methods (immunoassays, kinetic and cell-based assays)
- Analyze and present data internally and at customer’s meetings
- Lead characterization of early and late stage biotherapeutics (mAbs) using diverse biological assay formats
- Lead biosimilarity and comparability assessments
- Lead technology transfer to Just’s Quality Control laboratory
- Technical document authoring & author documents to support regulatory filings
- Contribute to team development by mentoring junior scientists
- Knowledge, skills and abilities_:
- Experience in biosimilars characterization specialized in mAbs
- Experience developing analytical methods in a CMC or GMP-like industry setting
- Expertise in qualification and/or validation of release potency and impurity methods
- Strong technical understanding of link between MoA and analytical method development; and effects of impurities on biological mAbs manufacturing processes
- Strong analytical skills and experience in statistical analysis
- Strong oral and written English communication skills
- French speaking would be an added value
- Experience and education_:
- PhD with 5+ years relevant industry experience, MSc with 10+ years’ industry experience degrees in Biochemistry, Molecular and Cell Biology, Bioengineering/Biotechnology or related field
- Other information_:
- Desire to work in a fast, collaborative, and team-oriented environment
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