About the Role
We are seeking a highly motivated Technical Operations Specialist to join our team.
The role is based in Ireland and involves approximately 20% travel to Europe.
Key Responsibilities:
* Manage technical issues relating to the global external manufacturing of commercial Drug Product.
* Take accountability and ownership for technical deliverables on assigned projects.
* Provide technical leadership within Technical Operations group for the management of sterile drug product.
Technical Expertise:
* Support technical transfers of new sterile drug product to contract manufacturing sites.
* Lead the resolution of technical issues relating to a product line or major technical projects within Technical Operation.
* Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing.
Leadership Skills:
* Act as primary interface on technical issues between Technical Operations and third-party drug product manufacturers.
* Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections.
* Organize and lead ad hoc cross-functional teams to manage investigations and implementation of CAPA and change controls.
Requirements:
* Bachelor's degree in engineering, biological/chemistry sciences, or related discipline.
* A minimum of 5 years of relevant work experience in manufacturing, including process start-up, routine manufacturing, and/or technical transfer.
* Experience in sterile/aseptic Drug Product processing, including formulation and filling, and technical transfers.
About Us
Career Wise Recruitment is a specialist recruitment agency operating in Ireland. We provide career opportunities in life sciences, ICT, engineering, food, and agri sectors.
Contact us today for more information about this role.