Senior Project Manager – Process Development

Job Description: Senior Project Manager – Process Development

Our client is a leading global biopharmaceutical company committed to developing and delivering innovative medicines for patients with serious illnesses. Its state-of-the-art manufacturing facility in South Dublin plays a key role in the manufacture and supply of high-quality biologic medicines to patients worldwide.

They are seeking an experienced Senior Project Manager – Process Development to lead New Product Introduction (NPI) and Lifecycle Management (LCM) projects at its South Dublin manufacturing facility. Working within the Portfolio Management and Delivery group, the successful candidate will lead cross-functional teams, establish effective project governance and manage integrated project plans from initiation through to close-out.

Key Responsibilities:

• Lead cross-functional NPI and lifecycle management projects for drug product and finished drug product manufacturing.
• Establish alignment across project teams, customers and management regarding project objectives, scope, deliverables and success criteria.
• Develop and maintain integrated project plans covering quality, scope, schedule, cost, resources, responsibilities and performance tracking.
• Translate project objectives into measurable execution plans and drive delivery against agreed milestones, budgets and readiness requirements.
• Lead project governance forums and core team meetings, ensuring effective decision-making, communication, follow-up and accountability.
• Partner with site subject-matter experts, functional managers and global stakeholders to align priorities and secure the resources required for project delivery.
• Manage project risks, issues, actions, decisions and dependencies, ensuring appropriate mitigation and remediation plans are implemented.
• Maintain control of project scope throughout execution and manage any changes through the appropriate governance processes.
• Generate and manage GMP change controls required to support project delivery.
• Communicate project status, risks, decisions and dependencies clearly to stakeholders at all levels.
• Influence and lead cross-functional and multinational teams without direct authority.
• Identify project gaps, resource constraints and competing priorities and implement practical solutions.
• Support the successful introduction of new products and the continued health of existing products through effective planning and coordination.
• Ensure all activities are completed in accordance with cGMP, EHS, quality-system, business and financial requirements.
• Promote a culture of accountability, compliance, continuous improvement and right-first-time execution.

Skills and Experience:

• Bachelor’s degree in a technical or scientific discipline is required; a Master’s degree or equivalent experience would be advantageous.
• Between five and eight years’ experience within the pharmaceutical, biotechnology or wider life sciences industry.
• A minimum of three years’ experience in project or programme management.
• Demonstrated experience leading cross-functional projects within a manufacturing, process development or technical operations environment.
• Experience supporting New Product Introduction, lifecycle management, portfolio management, resource planning or business-case development would be advantageous.
• Strong understanding of project planning, governance, risk management, stakeholder alignment and performance tracking.
• Proven ability to translate strategic goals and project objectives into clear, measurable execution plans.
• Strong stakeholder-management, influencing, communication and conflict-resolution skills.
• Ability to lead multidisciplinary and multinational teams within a matrix organisation.
• Strong capability in identifying risks, gaps and resource constraints and developing practical remediation plans.
• Ability to work independently, manage competing priorities and maintain delivery momentum.
• Knowledge of cGMP requirements and pharmaceutical quality systems.
• Experience generating or managing GMP change controls is strongly preferred.
• Working knowledge of Smartsheet, Microsoft Office, MS Project, PowerPoint and Visio.
• Experience with TrackWise change control and electronic document-management systems would be advantageous.

Contract Information

• Rate: TBC dependent on level of skills and expertise.
• Start Date: ASAP.
• Contract Length: 12 months contract, with a possibility of extension.
• Location: South Dublin.
• Schedule: Remote position with ad hoc travel on site.
• Eligibility: Candidates must hold an Irish, EU or UK passport, or a valid Stamp 1G or Stamp 4 permission to work in Ireland.