Study Manager Job in Harrogate, Yorkshire Uk

Study Director - Protein Analytical Chemistry-Covance.

My client is currently recruiting for a Study Director to join our Protein Chemistry Group within our Biotechnology Division. The Biotechnology Division, situated in Harrogate, North Yorkshire was established 20 years ago and is a fully GMP/GLP/GCP compliant facility providing a comprehensive portfolio of services including GMP cell bank production and storage, cell bank and viral vector safety testing, viral clearance services, biodistribution studies, analysis of biofluids using immunochemistry based techniques and extensive protein chemistry support including cGMP batch release and stability testing.
Recent major investments have been made in facilities on the Harrogate site and successful candidates will be part of our exciting and expanding future, working with progressive management, inventive technologies and alongside other talented scientists.

The Protein Chemistry department is focused on providing analytical support in the drug development pathway for the characterisation and stability assessment of large protein molecules, including: vaccines, antibodies, cytokines and growth factors. The accurate characterisation of a drug is necessary to release manufactured batches of the drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. This is achieved using a variety of analytical techniques such as: SDS-PAGE, Western blotting, Isoelectric focusing, Capillary electrophoresis, HPLC, UV spectrophotometry, ELISA, amino-acid analysis, peptide mapping, and Glycosylation analysis.

The Study Director ensures that the studies are carried out to the required standards and approves the study data. The Study Director 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. The primary responsibilities are listed below:

Ensure that the study is performed in accordance with the study protocol and the Covance standard operating procedures
Ensure that the study is performed to the required scientific and regulatory standards
In depth and up to date knowledge of UK/OECD GXP regulations as applicable, SD roles and responsibilities, organisation of multi-site studies
Holds start-up and ongoing study meetings
To be aware at all times of study status and anticipate problems that may affect timing, quality etc taking appropriate action to resolve such problems
Ensure that all study communication is documented and maintained and carried out to meet client requirements
Demonstrates knowledge of client requirements and plans accordingly (timelines, critical deadlines etc)
Provides client feedback to team
Produces study protocols and reports to meet client and regulatory requirements
Proactively manages client and study changes to meet timelines and ensure all additional costs are captured
In depth knowledge of relevant assays, able to advise internal/external clients on study designs
Responsible for on time delivery targets (protocols, results, reports)

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.

To apply for this position please apply directly to the Covance website www.covancecareers.com quoting the ref no: 28687