Description
Team Horizon is seeking an AD Technical Operations for our client in Dublin. This position is accountable for a high level of technology transfer projects while also assuming responsibility for a significant portfolio of marketed product support. This role will manage technical Staff at the Technical centre and will also have strong links with the Science and Technology group, which has multiple locations globally.
In addition, the team is responsible for identifying and executing technological improvements across the site's product portfolio competently and compliantly. The group also ensures that the site is supply-ready for all associated new products following major market and regional/local market launches.
Why you should apply:
1. This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
2. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
3. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
4. Lead technical fluency with all forms of OSD processes (dry powder blends, encapsulation, wet granulations, hot melt extrusion, compression and coating) and equipment.
5. Operate under dynamic conditions and rapidly adapt to evolving priorities and requirements
Display strong leadership capabilities and behaviours to engage, develop, manage and communicate with a diverse team of technically focused and specialised individual contributors
6. Deliver OSD tech transfer, process development, process scale-up, and validation.
Develop team to ensure top-tier technical and regulatory excellence in knowledge is maintained.
7. Champion New technology assessment and implementation.
Support alternate materials characterisation and qualifications.
8. Market & establish product process optimisation and remediation and support continuous process verification.
9. Ensure product launch/transfer supply robustness and readiness.
10. Manage small-scale manufacturing areas and promote their capabilities across the business.
11. Develop and drive the CPV program.
12. Interface with regulatory agencies when required.
13. Lead department initiatives and projects.
What you need to apply:
14. BS/MS/PhD qualification in pharmacy, chemical engineering, or related science field.
15. Proven experience in leading Pharma R&D and/or Mfg. Technical Services.
16. Acute end-to-end experience and understanding of cross-functional roles & responsibilities across the pharmaceutical industry’s development, tech-transfer, and launch phases, including regulatory considerations.
17. Strong collaborative analytical and problem-solving skills.
18. Strong leadership, communication and collaboration skills across Commercial, Operations, Regulatory and R&D.
19. Effectively delegate actions/tasks within a similar Tech Ops team and be resourceful in leveraging external partners (global support, vendors, academia, etc.).
20. Ability to see beyond short-term needs and think and plan strategically (5yrs, 10yrs)
21. Proficiency in computer skills with Microsoft Word, Excel, and Outlook.
22. Technical expertise in pharmaceutical technology and automated control systems
23. Understanding of Minitab and statistical methodologies