Project Leader – Analytical
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 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.