Job Description

Project Leader, Method Validation- Mayo

Ref No: SF17314

Mayo, Co. Mayo, Ireland

Competitive salary

Project Leader, Method Validation- Mayo

Core Purpose 

A Biopharmaceutical Client with New and existing laboratory facilities in Mayo are seeking an experienced Project leader to work on their new lab testing facility. The role will provide Technical Leadership and Project Management for new projects including New Product Introduction (NPI) and Product Development (PD).

Core Responsibilities:

  • 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.

Qualifications & Experience:

  • 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.

Apply below or contact Sean Fitzsimons at ICDS Recruitment for more details & to discuss the position in confidence 

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