R&D Senior Manager (Extractables and Leachables)

R&D Senior Manager (Extractables and Leachables)


Swords, Dublin or Waterford, Ireland

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.

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?

Do you have....

  • Excellent project management skills and the ability to effectively function in a fast-paced, dynamic technical environment?
  • Experience in extractables & leachables for pharmaceuticals & medical devices would be advantageous?
  • Knowledge of global regulatory and compliance requirements?
  • Experience of working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines?
  • Good planning and organising skills & adaptable to changing priorities?
  • Proficient in self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed?
  • Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles?
  • Proficiency with Microsoft Word, Excel, PowerPoint, Project (or related tools) and capable of maintaining appropriate project documentation?
  • Excellent communication skills (both oral and written)?

Apply Now

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