Scientist Upstream Process Development
Gene Therapy specialized company with a solid and promising pipeline of new R&D projects.
They have the purpose and possibility of changing lives by targeting the root cause of the disease rather than just treating symptoms. They use viruses and vectors to get into the cell to deliver the new copy of the gene into a cell.
PURPOSE OF THE ROLE
The Scientist Upstream Process Development will be responsible for managing all process development and characterization activities of several programs in pre-clinical and clinical stage.
This is a cross-functional position that involves an active communication between departments and across sites. The CMC Scientist will support the transfer of production processes from the pilot plant to the manufacturing facility.
As Scientist working in process development, you will be planning well designed experiments in cell culture and working with adeno associated viruses (AAV), fermentation technology, protein purification, supporting downstream, scale up and scale down activities, data analysis and interpretation.
- Becomes the point of contact and SME for process development matters (mainly in upstream and supporting downstream) and maintains a solid communication across departments as main representative of the CMC team.
- Accountable for early stage CMC programs and tech transfer to production
- Develop a flawless experimental planning, analyses results, reviews data and writes reports for upper management
- Management of bioprocess technicians
- Remain active in the scientific world by attending to conferences, writing journal articles and working together with the patent filing team
- PhD in Bio-Engineering or related scientific field (preferably with a solid background combination of engineering and biology studies)
- Solid track-record in process development (preferably in upstream processing)
- Preferably some experience with viral vaccines, gene therapies or complex biologics
- Proficient English communication and people or project management skills
- Pro-active, team player and problem solving personality