Analytical Project Lead

Work in a GLP or GMP environment with appropriate documentation and safety practicesLead the development and execution of analytical strategies for new drug product candidatesPlan, direct, and review laboratory work, including method development, validation, and transferDesign 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 developmentCollaborate with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriateCritically review and interpret scientific data to derive clear conclusions and provide direction for future workMentor and guide junior scientists in analytical techniques and data interpretation.Evaluate and implement new strategies as needed, e.g. working with external partnersCommunicate results and conclusions through various media including presentations and technical reportsAuthor relevant sections of the quality modules of regulatory submissions