Principal Scientist I
CurrentAs a Project Lead in Analytical Development, I was responsible for executing the development and validation of phase-appropriate analytical methods, providing critical technical support across various projects. I was actively involved in designing, authoring, and reviewing method validation and method transfer protocols, ensuring compliance with cGMP, FDA, and DEA regulations.Key responsibilities included:Leading method development and validation activities, ensuring successful implementation across multiple projects.Authoring analytical reports and compiling data for cGMP studies, adhering to FDA guidelines.Documenting deviations in TrackWise and conducting root cause investigations, implementing CAPA (Corrective and Preventive Actions).Performing gap analysis for supplemental validations and collaborating with other Cambrex sites for necessary testing.Serving as a Subject Matter Expert (SME) in the development and validation of cleanout methods to verify residuals in isolated intermediates and final APIs.Coordinating the transfer of validated methods to Quality Control and process support teams to ensure smooth operations.Collaborating with chemical development teams and providing technical expertise to optimize method development processes.Overseeing the management of controlled substances (CS) and supporting CS inventories within the Analytical Development department.Participating in the implementation of the LIMS system for efficient management of ELN, reference standards, and reagent inventories.Ensuring proper equipment maintenance and calibration and supporting departmental operations.Providing mentorship and training to junior scientists, fostering cGMP compliance, and promoting a collaborative, team-oriented environment.In this role, I utilized my technical knowledge and project management skills to lead complex projects, support cross-functional teams, and ensure the highest standards of quality and compliance.
