Project Manager - Tech Transfer
- Dundalk, Co Louth
- Contract
- Full-time
- Plan and execute multi discipline Tech Transfer projects (Drug Substance /Drug Product)
- Develop project controls (Project Execution Plans (PEP), schedules, risks, tracking and budgets)
- Lead the project team through all project phases to regulatory submission, engaging site teams (Tech Services, Operations, Engineering, Quality etc) as required
- 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.
- Develop project controls to ensure alignment of project timelines with business needs.
- Lead / Support rapid improvement projects through the application of the most appropriate project execution methodology for the given business challenge (Waterfall, Agile, Scrum, etc).
- Timely tracking of KPIs and reporting status to plan
- Work with project sponsors at initiation to ensure the project scope is fully defined and understood.
- Lead project management best practice by partnering with cross functional teams to ensure project execution is to plan.
- Resolve issues and escalate risks in a timely fashion to the relevant on-site and above-site stakeholders.
- A minimum of 6+ years industry experience with at least 4 of those years working in a project management role.
- Demonstrated leadership of technical and / or operational teams or projects within a biopharmaceutical manufacturing organisation
- Experience of product transfer across a network
- Experienced of biopharmaceutical Bulk Drug Substance manufacturing, Aseptic Fill Finish, and Ops readiness.
- Strong presentation and communication skills to multi- level stakeholders.
- Experienced in the application of project execution methodologies (Waterfall, Agile, Scrum etc).
- Proficiency in the use of project management tools / software
- Experienced in leading cross functional matrix project teams
- Experience in MPS/Operational Excellence – Green belt would be advantageous
- Minimum of a Bachelor’s degree in Operations Management, Engineering, Science or related field
- Experience in a Vaccines, Biologics or Sterile pharmaceutical manufacturing environment.
- Project management qualifications (e.g. PMP certification)