Fellow, MSAT Nitrosamine & Impurity Lead

About the role

The Fellow, MSAT Synthetics Nitrosamines and Impurity Management is a scientific authority ensuring a robust strategy for impurities potentially present in synthetic drug products, with a primary focus on the Nitrosamine Risk Assessment Strategy across the commercial synthetic portfolio. The role provides technical and scientific continuity from late development through commercial manufacturing and across the product lifecycle, operating as an individual contributor who influences through technical depth, systems thinking and mentorship.

Key responsibilities

• Provide expert leadership in impurity management across the synthetics portfolio, covering risk assessments and regulatory controls for drug substance and drug product, initially nitrosamines and later PFAS, extractables and leachables
• Work with manufacturing and synthesis chemists, formulation scientists and packaging engineers to optimise reaction parameters and adjust compositions or packaging; work with analytical and safety experts on control strategy
• Serve as the global subject matter expert on degradation pathways, extractables/leachables and impurity profiling
• Act as trusted advisor on the MSAT Synthetics Technical Review Committee and partner with development, toxicology, engineering, quality, regulatory affairs and supply chain teams
• Link with manufacturing sites and cleaning contractors on impurity carry-over and cleaning validation strategies, and represent the function in industry and regulatory fora
• Mentor partnering functions and act as a senior technical reviewer for CMC sections, supporting inspections, health authority interactions and lifecycle changes
• Guide BP2AL targets and post-launch impurity management to drive commercial improvements

Required profile

• Deep knowledge of ICH guidelines on impurity management
• Preferred skills include STEM application, technical credibility and research, and experience in process engineering and supply chain engineering