- Leading Pharma Company in the West of Ireland
- Excellent career progression opportunities along with a generous package.
We are presently seeking interest for an Analytical Project Leader to join our clients in Mayo.
We are seeking an experienced Analytical Project Leader for our Biologics Division located in Ballina, Co. Mayo, Ireland.
This role shall report to the Head of Analytical Strategy & Scientific Support 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 Analytical 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.
For more information about this position contact on +353 1 687 7188.
To apply at the above position, send your CV to firstname.lastname@example.org putting “Analytical Project Leader ” in email’s title.