R&D Project Leader - Biologics

ICDS Recruitment

Mayo

R&D Project Leader - Biologics - Mayo. Our leading Contract Research client is looking for aProject Leader for their Biologics Division located in Co. Mayo, Ireland. 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 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. Requirements: PhD in a relevant science discipline (e.g. Immunology, Virology. A minimum of 3 years relevant experience in Scientific Research in a GMP regulated environment. Experience in study design, assay development, ICH analytical validation and project management. Experience in in-vivo and in-vitro bioassays and model development highly desirable. Experience in immunology, immunogenicity and biosafety studies. Analytical techniques essential. Knowledge and experience with statistical software. This job originally appeared on RecruitIreland.com.

2345 days ago