Project Leader – Biosafety

This role shall report to the Head of Analytical Strategy & Scientific Support and the main duties & responsibilities shall be:

  • Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
  • Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
  • Draw up study plans and implement studies in strict accordance with study plan ensuring full GMP regulatory compliance as 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.
  • Generate risk assessments for various projects 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.
  • Experience in analytical techniques (e.g. HPLC, UPLC, GC, flame photometry, etc.) essential.
  • Ability to project manage multiple studies.
  • Knowledge and experience with statistical software.
  • Ability to problem solve and work on own initiative.

*This role is (Maternity Cover)

 

For more information please either call me on 087 922 1136 or email me at sean@arconrecruitment.com

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.