Project Leader - Analytical
We are seeking an experienced Analytical Project Leader for our clients Biologics Division located in Ballina, Co. Mayo, Ireland. Our client is a major player in the global life science sector and is expanding their facility in Mayo. This is a permanent role and you will join a busy and progressive company.
You will be welcomed into a highly personable environment which is designed to enable professionals to make a major contribution to the development of pharmaceutical products and therapies.
The successful candidate will be rewarded with a highly competitive salary which will be accompanied with health insurance, pension contribution and life assurance. Furthermore, your new employer will provide extensive training and support.
This role shall report to the Head of Operations Analytical and Biosafety 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 execute studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where 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 (ELS, CAD, etc.), 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.
Private Health Insurance