My client is looking for an experienced Project Leader for their Biologics Division. This is a permanent full-time position based in Ballina, Co. Mayo, Ireland.
Role & Responsibilities
- Draw up study plans based on the Client project and in collaboration with the Quality Department and the Ethical committee, as appropriate. Implement these studies in strict accordance with study plan ensuring full GMP regulatory compliance, Oversee the work of the operational team, ensuring it is conducted in accordance the with company’s SOPs and the general principles of GMP.
- Liaise with the Quality Department for the generation of audit responses, facility replies, GMP study plans, GMP study reports, deviation reports, generation, and update of SOPs, change controls and other quality documentation related to operations.
- Responsible for leading laboratory investigations where necessary.
- Responsible for reporting to Management: project progress; revenue recognition and related forecast activities.
- Provide technical and scientific training to the operational team as required.
- Day to day liaison with clients regarding current and new projects and coordination of meetings between all parts involved in a project.
- Involvement with regulatory and client audits, workshops, and technical visits.
- Research, develop and validate new methodologies to meet client requirements and/or company strategic objectives. Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
- Be involved in preparing costings and proposals based on study designs and inquiries supplied by clients.
- Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
- Ensure all documentation to import Client samples is generated or in place and conduct the risk assessments for various projects as required. Apply for a record of these samples in registers as appropriate.
Education & Skill Requirements
- PhD in a relevant science discipline (e.g., Biology, Biological Sciences, and related fields)
- 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, ICH analytical validation and project management.
- Experience in in-vivo bioassays and model development highly desirable. In-vitro bioassay experience is also valued.
- Experience in biological studies and in-vivo procedures is also desirable
- Ability to project manage multiple studies.
- Knowledge and experience with statistical software.
- Ability to problem solve and work on own initiative.
For a full Job Spec and to apply for this role please call Katie on +353 1 895 5770 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671