In this role, you will lead a Group responsible for the development of drug substance manufacturing processes ready for transfer to a manufacturing site, as well as the cell line development activities. Moreover, you will drive the establishment of a fully data-driven process development approach in close collaboration with the Drug Product & Analytics Group. We are looking for a highly motivated and collaborative individual with a passion for data-driven process development, who also enjoys working in a fast-paced, highly dynamic, and cross-functional working environment.
- Lead and develop the Drug Substance Group to meet current and future strategic requirements of the company.
- Develop efficient and robust drug substance manufacturing processes ready for transfer to clinical manufacturing.
- Support technology transfers to the clinical manufacturing sites.
- Collaborate closely with the Drug Product & Analytics Group to define requirements for in-process controls, as well as the Developability Group at earlier stages of projects.
- Ensure production of key materials during final lead optimization activities.
- MSc., PhD or equivalent in biology, chemistry, biochemistry, or a related discipline.
- Demonstrated industry expertise in the development of mammalian upstream processes for drug substance manufacturing.
- Clear understanding of the requirements for overall manufacturing processes incl. downstream process product quality, scalability, and robustness.
- English (written and spoken) skills suitable for day-to-day interaction, documentation and external collaborations.
- Proven ability to work independently, as well as across functions.
- Positive and proactive attitude.
Are you our new Drug Substance Leader? For any further questions or your application please contact: email@example.com.