Project Leader | Mayo

  • Leading Pharma Company in the West of Ireland
  • Excellent career progression opportunities along with a generous package.


The main duties & responsibilities shall be:

  • Oversee and lead the establishment/transfer of multiple methods from client to our test labs across a number of different disciplines.
  • Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
  • Draw up study plans and execute studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
  • Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
  • Responsible for leading laboratory investigations, where necessary.
  • Responsible for reporting project progress information to Management.
  • Provide technical training to scientific team, as required.
  • Day to day liaison with clients regarding current and new projects.
  • Involvement with regulatory and client audits.
  • Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
  • Generate new and update current standard operating procedures, where required.
  • Generate risk assessments for drug products, substances and processes as required.


The following are minimum requirements related to the Project Leader position.

  • PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
  • A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
  • Experience in study design, assay development, optimization, ICH analytical validation and project management essential.
  • Experience in analytical techniques, Molecular biology techniques e.g. PCR and Q-PCR or Cell Culture Techniques and Virology desirable.
  • Ability to project manage multiple studies.
  • Knowledge and experience with statistical software.
  • Ability to problem solve and work on own initiative.

To apply for the above offer send your CV to info@terrat.pl and put “Project Leader / Mayo” in email’s title.