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 workings for optimal utilization and resource agility. The position will provide leadership and operations support for manufacturing and release in addition to technology transfer, PPQ, inspection readiness and approval of new products. Leadership across the organization, including day and shift teams, is also required.
Our facility in Dunboyne joined our network in September 2020. The Dunboyne site is our company’s first Biologics Drug Substance Single‑Use Commercialisation Facility and plays a significant role in helping to commercialise key medicines.
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.
Develops and delivers toward site and organizational priorities and strategy.
Ensures 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.
Drives a strong compliance mindset within the organisation, including initiative‑taking safety and quality culture, and adherence to all regulatory expectations.
Owns the permanent inspection readiness.
Ensures production and project milestones are achieved through planning and execution of an integrated overall programme schedule.
Establishes and delivers 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.
Drives standardisation, execution, and operational excellence by applying Lean principles to foster a continuous improvement mindset to deliver a productive and cost‑efficient operating model.
Manages and develops operations team personnel toward strong, empowered leaders and builds, inspires, rewards, and develops diverse talent with the capabilities necessary to succeed in manufacture.
Develops facility and resource capacity model across areas within scope; resolves resource and prioritisation constraints and supports resource needs and changes.
Drives a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organisation and manufacturing processes.
Resolves issues and identifies risks in a timely fashion to relevant on‑site and above‑site stakeholders.
Prioritises proposed risk mitigation plans and/or accepts Quality Risks identified as part of the Quality Risk Management Process.
Provides 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.
Manages financial forecasts and workload to achieve departmental headcount and cost improvements.
Minimum Education and 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 and General Competencies
Strong leadership and interpersonal skills, including leading and coaching a direct team to drive a high‑performance organisational culture that accommodates rapid growth and 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 on‑site inspections.
Sound judgement and comfortable operating in a challenging, fast‑paced, and sometimes ambiguous environment.
Required Skills
Adaptability
Business Agility
Data Analysis
Decision Making
Driving Continuous Improvement
Financial Forecasting
Lean Design
Lean Manufacturing
Manufacturing Processes
Manufacturing Quality Control
Mitigated Risks
Operational Excellence
Operations Support
Organisational Culture
People Leadership
Process Optimization
Production Scheduling
Project Management
Regulatory Compliance
Results‑Oriented
Risk Mitigation Strategies
Six Sigma
Sterile Manufacturing
Strategic Initiative
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