• Lead the development and optimization of analytical methods for starting materials, intermediates and drug substances. Experienced with a wide range of techniques such as HPLC, GC, LC-MS, NMR, UV, FTIR, and other relevant analytical techniques to ensure method suitability for intended applications. • Design and lead method validation activities to ensure methods meet ICH, FDA, EMA, and other applicable regulatory guidelines. Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer. • Prepare, review, and approve technical documents such as standard operating procedures (SOPs), analytical study methods/protocols/reports, and product specifications. • Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert. • Collaborate with process chemistry scientists, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle. • Lead or contribute to multi-disciplinary project teams, manage analytical development timelines and communicate progress to stakeholders.