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
Employer:
MorphoSys AG
Location:
82152 Planegg-Martinsried