Senior Study Manager Job in Harrogate, Yorkshire Uk
Senior Study Director, Protein Analytical Chemistry - Covance
We are currently recruiting for a Senior Study Director within our Protein Analytical Chemistry department at our site in Harrogate, North Yorkshire.
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 primary responsibilities are listed below
Ensure that studies are performed in accordance with the study protocol and the Covance standard operating procedures
Ensure that studies are performed to the required scientific and regulatory standards
In depth and up to date knowledge of UK/OECD and 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)
Development, coaching and management of study directors.
About you
you will be educated to BSc/ MSc/ PhD or equivalent in a relevant scientific subject. You are expected to have relevant experience (study directing, 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.
We Offer
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 capabilities including method development/ validation, characterisation, cGMP batch release and stability testing.
To apply for this position please apply directly to the Covance website www.covancecareers.com quoting the ref no: 29354