Online Laboratory Magazine

Associate Director Quality Control (m/f/d)

  • Degree in Life Sciences, Pharmacy or Bioengineering
  • At least 8 years of experience in biotechnology or pharmaceutical industry with a minimum of 3 years of pertinent experience in the field of quality control
  • Solid understanding of GMP principles and regulatory requirements
  • Experience in instrumental analytics in the context of biopharmaceutical development as well as in QC life cycle management
  • Experience in the compilation of QC related content in submissions for late stage development projects
  • Coordinate and supervise analytical method transfers to CMOs and partners for the establishment of global manufacturing networks
  • Develop and supervise the life cycle management for analytical methods (implementation, validation, trending, continuous improvement) in a global manufacturing network
  • Provide QC input for process validation and compilation of Module 3 content for late stage development projects approaching global submissions
  • Contribute to the setup and maintenance of processes for analytical data handling in the context of sponsor oversight for our manufacturing networks
  • Contribute to strategic project planning for in-house and outsourced QC related testing activities
  • Represent QC in internal and external cross-disciplinary teams as responsible expert for method life cycle and analytical transfers

» Job description

MorphoSys AG
82152 Planegg-Martinsried