Project Leader, Analytical Services
On behalf of my client a global research organization, I am recruiting for a Project Leader to join the Analytical Services Team. This is a permanent offering great opportunity for career progression. In this role you will report to the report to the Analytical Services Department Manager and your responsibilities will include the following: 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. Candidates with the following background and experience are invited to apply: 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 a full Job Spec please call Deirdre on +353 1 2784671 or e-mail email@example.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671. This job originally appeared on RecruitIreland.com.
96 days ago