Senior Manager

Description:

In the role of R&D Senior Manager (Extractables and Leachables), you will be responsible for leading global, complex extractables and leachables (E&L) projects with internal and external laboratories. You will work with site and global teams to provide directional leadership in defining clear scope, study design and management of E&L studies that are required to support drug product marketing authorisation applications. The role will involve close co-operation with E&L and engineering SMEs, the manufacturing sites as well other involved departments for successful execution of projects. You will communicate at multiple levels of the organization and be responsible for recognizing and engaging key stakeholders quickly and early in the process. This role reports into the Director of R&D and is a Hybrid position that can be based in either Swords Dublin or Waterford.

A day in the life of our R&D Senior Manager (Extractables and Leachables)
 

• Main technical contact for Extractables and Leachables –(internal and external)
• Instigate and drive scientific and technical investigations developing multidisciplinary approaches to solve wide ranging, difficult and complex problems.
• Lead in designing and executing Extractables and Leachables studies.
• Project management of E&L studies, both internal and external, including planning, tracking, communication and escalations were needed.
• Produce, compile and review of detailed technical documents.
• Excellent communicator (both oral and written)
• Deliver high levels of customer service (both internal & external)
• Provide support to management with innovation and improvement of processes.
• Ad hoc support, as required.
   

Who We Are Looking For....

Are you….
 

• Degree, Masters or PhD qualified in chemistry (or related subject) with between 5 and 10 years’ industry experience preferably in the pharmaceutical industry?