This multinational pharmaceutical and biotechnology corporation is one of the largest producers of therapeutics in the world, with upwards of 50,000 employees and revenues north of 10 billion per annum. In recent years, this market leader has expanded it's footprint here in Ireland to not only include significant manufacturing operations, but additionally has started housing a number of key global roles and headcount, responsible for the organisation's contract manufactured product portfolio. As a result of additional CMO's coming online, this world leader now has a requirement for a remote working, Global DP Technical Operations Project Lead working within the organisation's Global Technical Group.
- Builds and manages the Schedule; this includes task forecasting and ensuring controls are in place to anticipate adherence / slippage vs plan and ensure mitigating actions are in place, as required.
- Establishment and management of routine team meetings to facilitate plan updates, decision-making, problem solving, escalations e.g. resourcing gaps, mitigations vs non-adherence to plan.
- The scope of the role typically covers Drug Product transfers (predominantly OSD or Sterile Injectables in formulation) to and between 3rd party sites; may also include other relevant changes such as API source changes and process optimisation project leadership.
- Provides timely and thorough project update reports to customers, via the established cadence and process.
- Partners with all other functions responsible for progress of the change project, typically Quality, External Supply Operations, Supply Chain, Artwork Team, Regulatory, and Receiving site CMO.
- Maintains oversight on project budget; manages project risks i.e. leads the development of risk assessment and mitigations with the Project Team.
- Administrative activities for the project such as action/issue item tracking, generation of meeting minutes, coordination of focused working sessions between sending and receiving sites and follow up on actions.
- Minimum of a degree in a Science or Engineering discipline with at least 5 years of project management experience. Project management skills to include experience of successful delivery of projects on schedule and to budget.
- Experienced ideally in pharmaceutical drug product manufacturing or oversight of CMO's manufacturing OSD or sterile product formulations.
- Strong knowledge of pharmaceutical manufacturing unit processes; understanding of the pharma regulatory environment, while not essential, would be advantageous.
- Excellent written and verbal communication skills. Ability to articulate a problem and communicate effectively.
- Intuitive and focused on achieving results.
- Well-developed interpersonal skills (leadership, integrity, team orientation, flexibility and creativity).
- Experience of working remotely in a matrixed and virtual environment.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321865 for a confidential discussion.