PhD. in Synthetic Organic Chemistry, Chemical Engineering, or related field and minimum 8 years relevant industrial experience in drug substance development.
Experience with DOE, statistical process control, PAT applications and Quality by Design (QbD) initiatives.
Strong working experience with HPLC, GC-MS, LC-MS, MS-MS, NMR and other supporting analytical technologies for chemical synthesis.
Knowledge of ICH Q7A and cGMP guidelines.