A global biopharmaceutical organization is seeking an Operations Executive Director to oversee Biologics clinical and commercial manufacturing. This pivotal role will drive transformational change and standardization across multiple facilities in Dunboyne, ensuring compliance and operational excellence. The ideal candidate will have over 15 years of leadership experience in a cross-functional manufacturing environment, particularly in Biologics. This position offers an inspiring challenge to lead and develop diverse teams, implement continuous improvement initiatives, and manage complex manufacturing processes. #J-18808-Ljbffr
Overview Job Description A fantastic and hugely exciting opportunity for an Operations Executive Director for Biologics clinical and commercial manufacturing at a single-use, multi-product commercialization facility in Dunboyne. Reporting to the Site Lead, this role will drive transformational change for capacity realization and operational excellence to deliver stable manufacturing teams and processes for a diverse and complex Biologics pipeline. This is a new position to establish single accountability across all manufacturing Operations at the site and to drive standardization and simplified ways of working for optimal utilization and resource agility. The position will provide leadership and operations support on Biologics drug substance (DS) and cell banking manufacturing and release, in addition to technology transfer, PPQ, inspection readiness and approval of new products. This role will include leadership across five facilities and 300 personnel within the organization, including days and shift teams. Responsibilities Responsible for all Manufacturing Operations within four state-of-the-art multi-product facilities used for clinical and commercial manufacture of Biologics Drug Substance, a Cell Banking facility and associated Weigh/Dispense and Solution Prep activities. Plans and directs all aspects of production activities associated with manufacturing or technology transfer and ensures that all projects, initiatives and processes are in conformance with established policies, standards and objectives. Serves on the Site Leadership Team for Operations to develop and deliver toward site and organizational priorities and strategy. Ensure right-first-time and stable start-up, including through technology transfer leadership, execution of clinical, PPQ and commercial batches, change management and implementation of process improvements. Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, and adherence to all regulatory expectations. Ownership for ensuring permanent inspection readiness is in place. Ensure production and project milestones are achieved through planning and execution of integrated overall program schedule. Establish and deliver on KPIs in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure. Drive standardization, execution, and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model. Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to succeed in manufacture. Develop facility and resource capacity model across all Operations on site. Resolve resource and prioritisation constraints and support resource needs and changes. Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes. Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders. Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process. Provide clear direction and definition of any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis. Manage financial forecasts and workload to achieve departmental headcount and cost improvements. General competencies Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high performance organizational culture that accommodates rapid growth and dynamic operating execution. Inspirational leader who leverages data to set the vision and drive outcomes. Desire to continuously learn, improve and grow, and cultivate continued development within the team. Innovative thinker with excellent decision-making and problem-solving skills. Ability to participate in and lead cross-functional teams, build diverse talent, with a passion to build the future of the Dunboyne facility. Ability to influence across organizational layers and externally with partners based on industry benchmarking. Ability to rapidly understand complex business and technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply and strategic initiatives. Strong communicator, decisive decision-maker with a proven ability to deliver excellence. Technical competencies Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean methodologies, with a track record in project management. Proven capabilities and knowledge of Biologics Drug Substance manufacturing, particularly in downstream processes. Set clear performance standards; hold ourselves and others accountable for achieving results. Knowledge of global and company health authority regulations and GMP requirements. Experience engaging with regulatory agencies including on-site inspections. Sound judgment and ability to operate in a challenging, fast-paced and sometimes ambiguous environment. Minimum Education/Experience Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies). Demonstrated leadership with at least 15 years leading in a cross-functional manufacturing environment, including indirect or direct people management experience. Demonstrated Biologics manufacturing and technology transfer experience. Required Skills Accountability Change Agility Data-Driven Decision Making Decision Making Driving Continuous Improvement GMP Compliance Leadership Lean Management Manufacturing Processes Operational Excellence Project Management Regulatory Compliance Preferred Skills Current employees or contingent workers considerations are handled per company process. Job Posting End Date 04/3/2026 Requisition ID R390933 #J-18808-Ljbffr
