Online Laboratory Magazine

Manager Quality Control (m/f/d)

  • Evaluation of external and internal QC related documents (batch records, analytical test methods, validation protocols and reports)
  • Support of establishment, maintenance and optimization of analytical methods for release and stability testing of biopharmaceutical products
  • Coordination of non-GMP as well as GMP compliant analytical studies for product characterization and process characterization/validation
  • Evaluation of analytical data and compilation of assessment reports
  • Maintenance of administrative tools for the supervision of external QC activities (e.g. method control charts)
  • Support of deviation handling, assessment of changes, OOS investigations
  • Interaction with internal and external project teams as analytical method expert
  • Degree in Life Sciences, Pharmacy, Chemical Engineering or Bioengineering
  • Strong analytical background with experience in instrumental analytics (preferably electrophoretic and chromatographic methods as well as bioanalytical assays)
  • Proven track record in biotech or pharmaceutical industry
  • Preferably experience with external manufacturing and testing sites (CTOs/CMOs)
  • Solid understanding of GMP principles

» Job description

MorphoSys AG
82152 Planegg-Martinsried