- Draw up study plans and implement studies in strict accordance with plan ensuring full GMP regulatory compliance.
- Liaise with the Quality Department for the generation of audit responses,
- Responsible for leading laboratory investigations.
- Responsible for reporting project progress information to Management.
- Provide technical training to scientific team as required.
- Research and develop new methodologies to meet client requirements and/or company strategic objectives.
- Responsible for generation of quotations for new studies and client enquiries.
- Ensure all new methods are validated in accordance with ICH guidelines
- Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
- Generate risk assessments for various projects as required.
- Act as Project Manager for in-vivo rodent studies.
Education & Experience
- MSc. or PhD in a relevant science discipline (e.g. Biomedical Science)
- A proven track record and experience of working in 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.
- Experience in immunology, immunogenicity, toxicity and safety studies. (analytical techniques also would be an advantage).