Your mission
We are actively seeking a Principal Pharmaceutical Scientist (m/f/d) for taking a key role in the development of a compounding system that will be used at hospitals (at the point of care) to prepare innovative injectable MRI contrast agents.
Tasks:
Tasks:
- As a pharmaceutical expert, you will lead projects of innovative drug developments, including drug substances and products (injectables), analytical and process development, and participate in validation, control strategy, and technology transfer in accordance with US/EU pharmaceutical regulations.
- These activities are part of the global development of a very innovative technology, combining quantum physics and sophisticated GMP compounding systems used at the point of care (Hospital).
- These activities will be done in collaboration with the Director of Chemistry, the Device Development team, the CMC Manager, and top tier CRO/CDMOs.
- You will have a pivotal and decisive responsibility in establishing pharmaceutical and regulatory expertises, technical strategies and best practices, for the formulation, process and analytical developments of our innovative drug products.
This includes: - Building methodologies and experimental plans following Quality by Design to develop robust processes and formulations, in deep collaboration with our research scientists, chemists and engineers.
- Characterizing and optimizing impurity profiles in collaboration with our CMC and non-clinical experts.
- Help to developing purification and sterilization processes (filtration) and their validations, in collaboration with our engineering and CMC managers
- Bringing expertise on and leading analytical development, validation and transfer with internal chemistry team, CRO and Users (Hospital)
- Leading process and stability validations, and participating in the generation of all necessary scientific packages for Module 3 and registrations.
- Participating in regulatory writing and interactions with health authorities under the supervision of Regulatory Affairs and CMC
- You will also be responsible for the management of technology transfer projects of our products to our CROs and CDMOs, as well as defining and negotiating work packages and contracts with them.