Operations Director

A fantastic and hugely exciting opportunity has arisen for an Operations Director for Biologics clinical and commercial manufacturing at our single-use, multi-product commercialization facility in Dunboyne. Reporting to the Operations Lead, this position will drive capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex biologics pipeline. This role will have leadership for one of the manufacturing areas (Upstream/Cell Banking, Downstream, and Solution Prep) spanning multiple facilities across the site, enabling standardization and simplified ways of working for optimal utilization and resource agility. This position will provide leadership and operations support for manufacturing and release in addition to technology transfer, PPQ, inspection readiness and approval of new products. This position will include leadership across the organization, including days and shift teams.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company's first Biologics Drug Substance Single Use Commercialisation Facility, playing a significant role in helping to commercialise key medicines. The innovation and collaboration between our Company's research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

Key responsibilities

• Responsible for all Manufacturing Operations used for clinical and commercial manufacture 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.
• 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 initiative-taking 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 KPI's 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 areas within scope. 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 ongoing basis.
• Manage financial forecasts and workload to achieve departmental headcount and cost improvements.

Your profile Minimum Education/Experience

• Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies).
• Demonstrated leadership with at least 10 years leading in a cross functional manufacturing environment, including indirect or direct people management experience.
• Demonstrated Biologics manufacturing and technology transfer experience.

Technical/General Competencies

• Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high-performance organisational culture that accommodates rapid growth & highly dynamic operating execution.
• Inspirational leader that leverages data to set the vision and drive outcomes.
• The 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 highly effective cross functional teams, build diverse talent, with a passion to build the future of our site in Dunboyne.
• Ability to influence across organisational layers, as well as outside the site and externally with partners and based on industry benchmarking.
• Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives.
• A great communicator, decisive decision maker with a proven ability to deliver excellence.
• Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean Methodologies and a proven track-record in project management.
• Proven capabilities and knowledge of Biologics Drug Substance manufacturing, particularly in downstream processes.
• Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
• Knowledge of global and company health authority regulations and applicable systems & GMP requirements. Experience engaging with regulatory agencies including in on site inspections.
• Sound judgment and comfortable operating in a challenging, fast-paced, and sometimes ambiguous environment.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.