Job Posting Study Director- Cell Based Assay (Biopotency)
We are currently looking for a Study Director with proven experience working within a GxP environment to join our growing Biotechnology department in Harrogate, North Yorkshire.
The Cell Based Bioassay Group
Part of the rapidly expanding Biotechnology Division, the Cell Based Bioassay group focuses on the support of the drug development process for large molecule biopharmaceuticals including vaccines, cytokines, growth factors, gene therapy vectors, clotting factors and antibodies. The project types include assessments of the biological activity (potency) of large molecules for batch release testing, product characterisation, candidate selection and stability assessment. In addition, immunogenicity studies are also performed to detect the presence of neutralising anti-drug antibodies during toxicology and clinical trials. Due to the varied nature of the projects, the Cell Based Bioassay group works in compliance with GMP, GLP and GCP guidelines.
Following recent major investment, successful candidates will be part of an exciting and expanding future, working with progressive management, inventive technologies and alongside other talented scientists.
The Study Manager is the single point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies allocated to him/her as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance. Dependant on experience, the Study Manager may manage complex customer programmes with multiple studies and/or have managerial responsibilities for other Study Managers.
Suitable candidates will have proven industry experience working within the field of cell biology / cell based bioassay (management of analytical teams or project management) in a regulatory environment (GLP/GCP/GMP). In addition, experience of client management and technical expertise in a relevant scientific arena is required.
Covance is a global market leader in contract research services, pioneering advanced studies into pharmaceuticals, biopharmaceuticals and agrochemicals across the globe. We partner with innovative companies, offering valuable services in all phases of the development process. As an integral part of these partnerships, our diverse and highly skilled employees make a difference in the lives of millions. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Education/Qualifications . Experience . Covance - 12 months ago