Aufgaben

  • Develop, assess, optimize, and apply analytical methods using HPLC, UPLC, GC (with various detection modalities such as PDA, FLD, MS), HR-MS, IC, NMR, FT-IR, Raman, UV/Vis, color/turbidity analysis, Karl Fischer titration, and particle size distribution
  • Characterize APIs with low solubility, including techniques for amorphous solid dispersion, and perform dissolution, content uniformity, and related substances analysis
  • Conduct release, retest, stability studies, transfer, and (pre-) validation analyses
  • Write and review analytical method protocols, development reports, and ensure proper documentation of all analytical activities
  • Plan and execute experiments for method development, optimization, and application, including forced degradation studies
  • Maintain and operate analytical equipment, ensuring adequate maintenance and operation
  • Participate in intra- and inter-departmental meetings (e.g., CMC, specific working groups)
  • Draft and review CoAs, analytical result sheets, and SOPs
  • Train laboratory personnel and ensure cleanliness of laboratory and workspace
  • Independently design and execute projects or experiments with hands-on involvement
  • Review scientific work related to project activities and ensure availability of lab materials, justifying acquisition of new materials or equipment when necessary
  • Basic knowledge of GMP is advantageous

Qualifikationen

  • Proficiency in HPLC, UPLC, and GC with various detection modalities
  • Expertise in HR-MS for determining assay, purity, related substances, and impurities
  • Skilled in IC for cation and anion determination
  • Competence in NMR for structure confirmation and impurity determination
  • Experience with spectroscopic techniques such as FT-IR, Raman, UV/Vis, and color/turbidity analysis
  • Knowledge of Karl Fischer titration for water determination
  • Ability to perform particle size distribution and shape analysis
  • Understanding of API characterization techniques for low solubility substances
  • Strong documentation and analytical data interpretation skills