AbbVie is seeking a Technical Operations API Lead to provide technical support, program management, and team leadership within Technical Operations. This role supports manufacturing operations, new product introductions (NPIs), process improvement, and technical transfer activities, with responsibility for leading the Technical Operations API and Small Scale Cell group at our site in Sligo.
In this role, you will ill work cross-functionally to support site objectives, improve process performance, reduce costs, and ensure compliance with cGMP, EHS, and regulatory requirements.
Key Responsibilities
- Provide technical support for manufacturing issues, including troubleshooting, optimisation, cost reduction, training, and coaching.
- Lead technical and validation activities during project start-up and new process introduction.
- Identify, manage, and deliver continuous improvement initiatives across the site.
- Support feasibility studies, operating budgets, and planning for future product introductions.
- Lead technical transfers for future product introductions to AbbVie.
- Manage medium-scale capital projects as assigned.
- Optimise processes and equipment to improve product quality, yields, throughput, and operational performance.
- Lead process development projects on existing products and late-stage clinical products, including scale-up to plant equipment.
- Provide leadership, coaching, mentoring, and performance management for direct reports.
- Ensure adherence to EHS, cGMP, HPRA/FDA, company policies, procedures, and guidelines