Analytical Project Lead

Work in a GLP or GMP environment with appropriate documentation and safety practices· Lead the development and execution of analytical strategies for new drug product candidates· Plan, direct, and review laboratory work, including method development, validation, and transfer· Design and interpret stability studies to understand degradation mechanisms and support shelf-life assignments.· Develop impurity control strategies aligned with regulatory expectations.· Collaborate with formulations, process and regulatory teams to ensure seamless pharmaceutical drug development· Collaborate with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate· Critically review and interpret scientific data to derive clear conclusions and provide direction for future work· Mentor and guide junior scientists in analytical techniques and data interpretation.· Evaluate and implement new strategies as needed, e.g. working with external partners· Communicate results and conclusions through various media including presentations and technical reports· Author relevant sections of the quality modules of regulatory submissions