NVision Imaging Technologies

Manager

• 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

CMC Development Manager