In this role, you will play an important part in the development of drug product formulations and analytical methods. You will use established analytical methods to assess DP stability. We have adopted the ambitious standard of developing robust formulations and qualified analytical methods ready for transfer into a cGMP-regulated environment. This role is highly cross-functional, and you will work in close collaboration with our Drug Substance group and the Developability Group. We are looking for a highly motivated and collaborative individual with a passion for data-driven development, who also enjoys working in a fast-paced, highly dynamic, and cross-functional working environment.
Key Responsibilities
- Develop robust DP formulations and qualified analytical methods ready for transfer to clinical manufacturing and testing sites.
- Support technology transfers to the clinical manufacturing/testing sites.
- Collaborate closely with the Drug Substance Group and the Developability Group at earlier stages of projects.
- In-house drug product production and stability assessment/confirmation.
Your Profile
- Trained technician with min 5 years of relevant experience, B.Sc., M.Sc. or equivalent in biology, chemistry, biochemistry, or a related discipline.
- Demonstrated industry expertise in the development of analytical methods such as SE-, IEX-, and RP -HPLC, as well as drug product development with focus on formulation and DP stability.
- General understanding of the principles of biotechnological manufacturing processes incl. drug product quality is a plus.
- 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 pro-active attitude.
Are you interested? For any further questions or your application please contact: wolfgang.kress@cdr-life.com