We are looking for a Technical Lead to provide technical expertise and leadership in the design, execution, and reporting of reverse engineering studies for new pharmaceutical products. This is a lab-based role requiring in-depth knowledge of analytical method development/validation and a strong understanding of current regulatory guidelines, particularly EMA and FDA standards.
Key responsibilities include:
To lead the design and execution of reverse engineering studies to support the development process for pharmaceutical equivalence projects
To develop and validate analytical methods, where required, to support reverse engineering studies in accordance with the relevant guidelines
To lead and support the development and validation of dissolution studies within the department.
Provide technical support to the pharmaceutical development team to aid in troubleshooting of analytical methods.
To identify and implement continuous improvements within the pharmaceutical development department
Support the preparation of documentation and responses to regulatory submissions and queries
We are seeking an experienced professional with a passion for pharmaceutical innovation and strong leadership skills to drive success in a dynamic, collaborative environment.