ID EXISTS
POS 3062
Status 10
DJM 1

Analytical Expert Late-Stage

Beschreibung: For one of our German Biotech clients in Bavaria we are seeking freelance support as: Late-stage Analytical Expert (M/F/D)
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Tasks:
  • Review process characterization and validation protocols and reports
  • Draft and review product characterization protocols and reports (e.g. Forced Degradation Studies, PTM-analysis studies)
  • Contribute to CQA assessments and qTPP generation
  • Contribute to the overall analytical strategy of a phase III biologics development program with the focus on BLA generation
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Qualification:
  • At least 3 years of experience in the analytical / QC department within the (bio)pharmaceutical industry
  • Antibody expert with significant experience through various stages of clinical development towards BLA
  • Experienced in evaluation of data gained from chromatographic and electrophoretic methods (HP-SEC, cIEF, CIEX, CGE) and activity/potency assays (SPR, ELISA, cell-based reporter bioassays)
  • Experienced in degradation pathways of proteins
  • Experienced in evaluation of mass spectrometry data, especially in peptide mapping and post-translational modifications
  • Experience in performing mass spectrometry is a plus, but not mandatory
  • Experience in preparation of BLA chapters and/or control strategies is highly desired
  • Must Have: Business fluency in English
  • Nice to Have: German
Bemerkungen: WANTED: Analytical Expert Late-Stage (M/F/D). Please contact +49 89 18 90 998 35 or christian.braumueller@k-recruiting.com Skills: English, QC (Quality Control)
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 12 months
Einsatzort: Bavaria
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