MSAT Senior Professional
- Dublin
- Permanent
- Full-time
Location: Dublin , , Ireland
Contract type: Permanent
Job ID: 3680We have a new opportunity for an experienced MSAT Senior Professional to join our talented team in Dublin!Join us in creating a future legacy in medical dermatology.At LEO Pharma, we are global leaders in medical dermatology. We have 115 years' experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines.As an MSAT Senior Professional with LEO Pharma, you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.In the MSAT team, we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals. The ideal candidate will be able to work collaboratively as part of a global team.Your RoleYou will lead process development and technology transfer projects, providing both process and technical support. You will proactively promote and support process improvement initiatives and the commercialisation of new products. The key responsibilities of the position include, but are not limited to:
- Role model winning behaviours - Collaborate, Prioritise & Simplify and be Accountable & Own It.
- Providing technical support to Manufacturing Dublin and/or CMO production.
- Leading process improvement and development projects.
- Implementing new process technology, leading technology transfer and NPI project teams.
- Providing CMC input to regulatory submissions and health authority interactions
- Maintaining, updating and approving relevant sections of the CTD (Module 3)
- Evaluating proposed changes to processes, equipment and raw materials
- Reviewing documentation relating to production.
- Executing process PQ and PV activities resulting from process development or process optimisation.
- Monitoring robustness of processes through use of OPV
- Assessing the impact of process-related deviations, including requirements for the execution of investigational stability testing
- Training personnel in the area of existing or new process developments.
- BA Hons degree in Pharmacy, Chemistry or other Third level science qualification
- Prior experience in the Pharmaceutical industry (min of 1 year) or in appropriate post-grad 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, fostering cooperation and resolving conflicts constructively within a complex and global environment.
- Effectively manage issues systematically, developing innovative solutions, through data-driven decision making.
- Aligning process changes with organisational goals, balancing feasibility with business needs.