Your mission
As a CMC Development Manager (m/f/d), you will be a key leader in advancing our innovative drug development program. You will take ownership of the development of our products, from analytical method development and validation to drug substance and drug product manufacturing processes optimization. Working closely with multidisciplinary teams and external partners, you will ensure our processes and products meet the highest standards of quality, scalability, and regulatory compliance.
Key responsibilities:
Key responsibilities:
- Lead process development activities, including manufacturing process optimisation, material qualification, and compatibility testing internally and with contractors
- Work closely with R&D to develop and then manage validation of analytical methods for identity, purity, and impurities, utilizing techniques such as UV–Vis, NMR, HPLC, GC, and Raman internally or with contractors
- Design stability studies and impurity profiling to ensure processes are reliable and fit for purpose.
- Drive drug product development activities, including formulation and sterile process design
- Play a key role in coordinating interactions with third-party CDMOs to support outsourced activities.
- Support scale-up and technology transfer to clinical manufacturing sites.
- Prepare and review CMC documentation, including experimental reports, protocols, SOPs, and eCTD sections.
- Work across development, quality, regulatory, and supply chain teams to keep projects aligned and on track.