Leonie Hünig, MScSenior Consultant and Project Manager

Leonie is a specialist for Project Management in the development of Medical Devices and Combination Products. She has gained experience in global pharmaceutical companies, managing the development of mechanical pen-injector and autoinjector devices. Within the projects, she is acting as the main interface between the development team, vendors and external partners.

She is familiar with the overall design control process including design verification and validation, as well as cGMP and project documentation in accordance with regulatory requirements like 21 CFR 820.

In her free time she enjoys music and scuba diving.

Expertise:

  • Project Management
  • Combination Products
  • Medical Devices
  • Design Control
  • Pen Injector Devices
  • Autoinjectors
  • Pre-filled Syringes