We're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
1. Plan and execute multi discipline Tech Transfer projects (Drug Substance /Drug Product)
2. Develop project controls (Project Execution Plans (PEP), schedules, risks, tracking and budgets)
3. Lead the project team through all project phases to regulatory submission, engaging site teams (Tech Services, Operations, Engineering, Quality etc) as required
4. Project management of selected projects within the site's project portfolio, potential projects could include process improvement, new system delivery and NPI (New Product Introduction) projects in our Drug Product specialism.
5. Develop project controls to ensure alignment of project timelines with business needs.
6. Lead / Support rapid improvement projects through the application of the most appropriate project execution methodology for the given business challenge (Waterfall, Agile, Scrum, etc).
7. Timely tracking of KPIs and reporting status to plan
8. Work with project sponsors at initiation to ensure the project scope is fully defined and understood.
9. Lead project management best practice by partnering with cross functional teams to ensure project execution is to plan.
10. Resolve issues and escalate risks in a timely fashion to the relevant on-site and above-site stakeholders.
Education & Experience
11. A minimum of 6+ years industry experience with at least 4 of those years working in a project management role.
12. Demonstrated leadership of technical and / or operational teams or projects within a biopharmaceutical manufacturing organisation
13. Experience of product transfer across a network
14. Experienced of biopharmaceutical Bulk Drug Substance manufacturing, Aseptic Fill Finish, and Ops readiness.
15. Strong presentation and communication skills to multi- level stakeholders.
16. Experienced in the application of project execution methodologies (Waterfall, Agile, Scrum etc).
17. Proficiency in the use of project management tools / software
18. Experienced in leading cross functional matrix project teams
19. Experience in MPS/Operational Excellence – Green belt would be advantageous
20. Minimum of a Bachelor's degree in Operations Management, Engineering, Science or related field
Desirable Experience & Qualification:
21. Experience in a Vaccines, Biologics or Sterile pharmaceutical manufacturing environment.
22. Project management qualifications (e.g. PMP certification)
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.