We’re looking for a candidate to fill this position in an exciting company.
Review and interpret raw data to produce good quality process knowledge and data sets suitable for inspection by regulatory agencies.
Professional development to take up the role of Study Director, who has the overall responsibility of the planning and conducting, as well as the interpretation, analysis, documentation and reporting of results. Design the viral clearance study in accordance with guidelines (e.g. EMEA and ICH Q5A).
Authoring of protocols and reports and interaction with regulatory agencies are required.
Supervision of project teams and leading troubleshooting activities may be required.
Develop and manage relationships with external customers and teams at contract testing laboratories.
Deliver high quality communication to ensure an outstanding customer experience (written reports, telecons, face to face meetings).
Working as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project workstages.
Degree/PhD in Biological Science/Engineering as appropriate for area of expertise.
3-5 years’ experience or 1-3 years and a PhD with experience gained in a lab either in industry or academia, or via an industry work training programme.
Practical laboratory experience in virus clearance studies, study directing and project management is required.
Developing a detailed understanding of the scientific rationale behind one or more technical areas involved in the development of biopharmaceuticals.
The final role offered will be commensurate with the candidate’s experience.
Understanding of cGMP regulations and quality management is required.