CMC Development Manager
NVision Imaging Technologies
full-time
Posted on:
Location: 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Take ownership of product development from analytical method development and validation to drug substance and drug product manufacturing process optimization
- Lead process development activities including manufacturing process optimisation, material qualification, and compatibility testing internally and with contractors
- Develop and manage validation of analytical methods for identity, purity, and impurities using 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
- Coordinate 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
Requirements
- MSc or PhD in chemistry, pharmaceutical science, chemical engineering, or a related field
- At least 5 years of experience in analytical chemistry, process development, or manufacturing within the pharmaceutical or biotech industry
- Demonstrated expertise in CMC development, including manufacturing process validation and technology transfer
- Strong background in analytical method development and validation (NMR, GC, HPLC) preferred
- Strong understanding of and experience working in an environment compliant with GMP, GLP, and ICH guidelines
- Very good written and spoken English skills