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.
The new scientist will join a fast-paced, collaborative, and multidisciplinary team to develop and execute methods for the functional & potency assessment and impurity monitoring of biotherapeutics (mAbs). As a key member of the analytical group, the successful candidate will have experience in immunoassay, cell-based assay and qPCR method development and qualification/validation, as well as strong experimental design and data analysis skills. Previous experience in biosimilar development, participation in CMC (Chemistry, Manufacturing, and Controls) teams and experience authoring regulatory documents is highly desirable.
The ideal candidate has strong written and verbal communication skills in english, multitasks effectively, works well independently and in teams.
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
- Experience developing and applying biological characterization methods (e.g. cell-based assays, Fc receptors binding kinetic assays – SPR & BLI, immunoassays) and in technology development pertinent to impurities
- 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
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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