Ref No: AM17340
Co. Dublin, Ireland
Operations Core Team Leader - South Dublin.
This position is being offered as a 12-months fixed-term contract.
In this role you will lead and co-ordinate all aspects of the Operations responsibilities through product / process development, equipment installation, validation, pilot and industrial production start-up, together with post-launch customisations and range extensions.
You will work within a core team led by the Project Core Team Leader and represent Operations as Core Team Member on the team, while functionally reporting to the Director, for Advanced Drug Delivery Solutions.
You will lead Engineering, Manufacturing and Operations resources allocated to the project, so a high level of collaboration is required to collaborate with the cross-functional project team, internal manufacturing network, suppliers, worldwide functions, and business platform leadership, to execute project and manufacturing deliverables on time and budget.
Main responsibilities will include:
Act as Operations Core Team Leader for large and strategic projects, responsible for all Operations work through the project phases.
Responsible for supporting development of the product manufacturing strategy and the execution of tactical implementation plans.
Completion of assigned activities and projects within technical scope, budget and on schedule.
Lead, motivate and develop direct reports to meet business and personal goals.
Define project expense, resource and capital requirements aligned with manufacturing strategy and control of spending to budget and forecast.
Provide manufacturing guidance to product design to ensure acceptability for scale-up in line with cost projections.
Co-ordinate Operations requirements for the project through concept, development, pilot production and full industrialisation, working in conjunction with global support functions (Supply Chain, Procurement, Worldwide Engineering) and internal / external global manufacturing networks.
Improve cell efficiency so capacity is adequate to service the increasing business needs.
Define equipment specifications and be responsible for equipment procurement, installation and validation at the selected manufacturing site (internal plant or external supplier).
Develop material sourcing plans, working with Global Procurement, and responsible for pre-commercial product manufacture and delivery in accordance with project requirements and implementation of pilot and industrial manufacturing capacity, in line with cost and delivery targets and compliant with cGMP and Safety standards.
Interested applicants should have a primary degree in Mechanical, Electrical, Electronics or other relevant engineering area, and have a vast manufacturing experience, coupled with product manufacturing transfer, project management and specification/implementation of manufacturing equipment/processes.
Some of this experience to have ideally been gained within the medical device, pharmaceutical, or other regulated industry.
The ideal candidate will have knowledge of a wide variety of manufacturing processes including assembly, inspection methods, injection moulding, packaging and sterilisation. You will understand business financials, product cost drivers and will work in accordance with and compliance to applicable standards and regulations.
You must have the ability to work, communicate and influence decision-makers across multiple sites/regions/levels within the organisation. Collaborative interaction with colleagues from other departments, businesses and suppliers through leading/participating on project teams. You will have strong people leadership skills and a proven track record of delivering results.