Title: Project Leader - Biosafety and Bioassay Development
Location: Co. Mayo, Ireland.
Project Leader will report to the Biosafety and Bioassay Development Manager.
- Compose study plans and execute studies in strict accordance with study plan guaranteeing GMP regulatory compliance.
- Communicate with the Quality Department for the generation of creation of audit responses, facility replies, deviation reports and collection of study reports.
- Supervise leading laboratory investigations.
- Accountable for reporting project updates to Management.
- Supply technical training to scientific team.
- Daily liaison with clients regarding current and new projects.
- Participation with regulatory and client audits.
- Research and develop new methods to meet both client requirements and/or company strategic objectives.
- In charge of generation of quotations for upcoming studies and client enquiries.
- Responsible for providing weekly and monthly sales figures for certain studies.
- Make sure all new methods are validated in accordance with ICH guidelines.
- Certify all new equipment is qualified and validated in accordance with GMP and corporate validation requirements, standards, and guidelines.
- Create new and upgrade current SOP's.
- Generate risk assessments for numerous projects.
- Act as Project Manager for in-vivo rodent studies.
Education and Experience:
- MSc or PhD in 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 the following: study design, assay development, ICH analytical validation and project management.
- HPRA project license authorisation is desirable.
- Experience in in-vivo Bioassays and model development.
- Experience in immunology, immunogenicity, toxicity, and safety studies (analytical techniques are advantageous).
- Capability to manage various studies.
- Knowledge and experience with statistical software.
- Skills to problem solve and to work on own initiative.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.