Project Leader, Biopharmaceuticals

CPL

Mayo

On behalf of my client, a global contract research laboratory, I am recruiting for a Project Leader to join their Biologics facility in the West of Ireland. The successful candidate will report to the Analytical Services Department Manager and will have the following responsibilities:  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, facility replies, 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.  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.  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. Applications are invited from candidates with the following background and experience: • PhD in a relevant science discipline (e.g. Immunology, 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 methods. • Experience in analytical techniques (e.g. HPLC, UPLC, SDS-PAGE, Western Blot, qPCR, ELISAs) essential. • Ability to project manage multiple studies. • Knowledge and experience with statistical software. • Ability to problem solve and work on own initiative. For more information and to apply for this role please call me on 01 2784671 or e-mail dbolger@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. This job originally appeared on RecruitIreland.com.

2037 days ago