Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.
Oxford Biomedica’s Analytical Development group is seeking to expand and strengthen its team by recruiting an experienced scientist to support the development validation needs of an increasing portfolio of cell and gene therapies. The group is responsible for assay development and subsequent validation to support the GMP manufacturing process and early phase development through to commercialisation. The role requires the ability to work in a multi-disciplined innovative environment whilst also adhering to internal and external quality systems. The Analytical Development Group is part of the research group but works closely with manufacturing, clinical and analytical services at all stages of development.
A highly motivated individual is sought to work within this team. The successful candidate will be expected to:
Perform validation of new and existing assays and equipment to support the development of Oxford Biomedica’s pipeline
Evaluate and implement new technologies to improve the performance and efficiency of analytical work streams
Support the development and clinical manufacture of ATMPs
Key responsibilities and accountabilities:
Identifying, evaluating and validating new analytical methods and technologies within a GMP environment
Troubleshoot assay performance issues as and when required
Drafting and preparation of standard operating procedures for new assays and updating existing ones following validation
Act as project manager for validation and qualification studies, training members of the Analytical Services Group (ASG) to perform newly developed and validated assays
Assist with other activities undertaken in the research group as required
Key skills and requirements:
Strong biochemistry and molecular biology skills especially around, but not limited to, DNA, RNA, quantitative PCR and/or protein analysis from a minimum of BSc or MSc in Biochemistry, Biotechnology, Molecular Biology or Analytical Science and industry experience
Practical industry experience in analytics and development projects/activities
Experience of working in a regulated environment (GMP/GLP/GCLP)
A strong background in assay development and validation
Knowledge of ICH guidelines would be desirable
Good level of presentation as well as written and verbal communication skills
A highly motivated individual with the proven ability to work collaboratively both independently as well as in a team
Have excellent planning and organisational and time management skills
Ability to undertake projects to agreed timelines and adapt to rapid changes in project priorities
The ability to train others in the conduct of analytical techniques