MSAT Senior Professional

6 days ago

Dublin, Dublin City, Ireland LEO Pharma UKIE Full time
Overview

We have a new opportunity for an experienced MSAT Senior Professional to join our talented team in Dublin. This is a Permanent role with an application deadline of 12/09/2025 (location: Dublin, Ireland).

LEO Pharma is a global leader in medical dermatology with 115 years of experience. We aim to improve daily living for people with skin diseases and foster a culture of collaboration, innovation and accountability.

As an MSAT Senior Professional, you will help shape the future of our products by advancing the standard of care and supporting global process development and technology transfer initiatives.

Responsibilities
  • Role model winning behaviours - Collaborate, Prioritise & Simplify and be Accountable & Own It.
  • Provide technical support to Manufacturing Dublin and/or CMO production.
  • Lead process improvement and development projects.
  • Implement new process technology, lead technology transfer and NPI project teams.
  • Provide CMC input to regulatory submissions and health authority interactions.
  • Maintain, update and approve relevant sections of the CTD (Module 3).
  • Evaluate proposed changes to processes, equipment and raw materials.
  • Review documentation relating to production.
  • Execute process PQ and PV activities resulting from process development or optimization.
  • Monitor robustness of processes through use of OPV.
  • Assess impact of process-related deviations, including requirements for investigational stability testing.
  • Train personnel in existing or new process developments.
Qualifications
  • BA Hons degree in Pharmacy, Chemistry or other third-level science qualification.
  • Prior experience in the pharmaceutical industry (min 1 year) or suitable post-graduate research, or a combination of both.
  • Formal qualification in process improvement (e.g., Lean Six Sigma) or project management (e.g., PMP, PRINCE2) is an advantage.
  • Familiarity with Module 3 of the Common Technical Document. Experience with regulatory variations and health authority interactions is an advantage.
  • Experience in semi-solid formulation or drug product manufacturing is an advantage.
  • Ability to build and develop effective relationships and foster cooperation within a global environment.
  • Data-driven decision making and systematic issue management with innovative solutions.
  • Ability to align process changes with organizational goals and business needs.
Additional information
  • This is a site-based role at our Dublin facility, with hybrid working arrangements possible under our remote working policy.
  • Background check may be conducted by a third party for certain positions.
  • Report a concern: Whistleblower hotline | LEO Pharma

To apply, you may note in your CV why this position interests you. A photograph should not be included with the CV.


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