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  • Location: Newry
  • Salary: Competitive Salary
  • Job Type:Permanent

Posted 10 days ago

  • Sector: Scientific Development
  • Contact: Georgie Lamberth
  • Contact Email: georgie.lamberth@nextphaserecruitment.com
  • Contact Phone: 01403216216
  • Start Date: ASAP

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.