Senior Scientist, Translational Services (12 month Mat Cover)
- Experience Level
- Experienced (non-manager)
Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.
Oxford Biomedica’s Translational Sciences Group is responsible for supporting and optimising the development of internal and external therapeutic products through preclinical and clinical research, utilising high quality bioanalytical assays to provide a detailed understanding of safety and efficacy parameters
We are currently recruiting for a Senior Scientist to join the team for a twelve month maternity cover. The purpose of this role is to plan, execute, co-ordinate and report GxP analytical investigations for immunogenicity and transgene expression of EIAV/HIV based vectors in clinical and non-clinical samples in accordance with GLP and GCP(Labs) compliance
Your responsibilities in this role would be:
- Provide analytical and sample management support and expertise to the Study Directors (SDs), Principle Investigator (PIs) and Analytical Project Managers (APMs) with the scope to become an SD/PI/APM
- Plan, execute, co-ordinate and report GLP/GCP investigations into the immunogenicity or transgene expression of EIAV/HIV gene therapy products by various immune-assays (e.g. ELISAs, ELISpots, and Western blotting techniques) in accordance with GCP/GLP compliance
- Co-ordinate and perform FACS/ELISA analytics to support the development, manufacture and release of EIAV/HIV vectors in accordance with GMP compliance as appropriate
- Ensure a high standard of record keeping, reporting and interpretation of results, quality control checks of assay packs, compliant with GxP regulations as appropriate
- Responsible for completion of QA audit reports performed on any GxP assays performed
- Responsible for the completion of QA audit reports of GxP facilities, and/or be person responsible for a GxP laboratory, supporting the maintenance of GxP compliant facilities (e.g. performing and co-ordinating general laboratory duties such as calibration, monitoring and cleaning of equipment)
- Management of critical assay controls, including conduct of qualification/verification studies
- Produce and maintain high quality GxP documentation (e.g. SOPs, equipment files, deviations, CAPAs, change controls) and be able to advise junior team members
- Lead the improvement of current assays and/or implementation of new validated analytical techniques, and/or transfer of assays from other departments, when required, ensuring the assays and equipment meet the relevant compliance standard
- Drive continuous quality improvement with the compliance with GLP/GCP regulations
- Support and train other TSG members and supervise junior team members as required
- Share scientific knowledge through regular team/department meetings and presentations
To be successful in this role, you will have the following skills and experience:
- BSC/PhD or extensive relevant experience in an associated subject
- A detailed knowledge and experience of one of GLP, GCP(Labs) or GMP compliance
- Laboratory technical experience with particular emphasis on one or more of the following: ELISAs, Western blotting, ELISpots, FACS analysis
- Knowledge of regulatory requirements e.g. GMP, GLP, GCP and Quality Management systems and ability to maintain compliance, and capability to train others
- Excellent laboratory skills and understanding of bio-analytical methodologies with expertise in one or more areas e.g. ELISAs, Western blotting, ELISpots, FACS, and responsible for training others
- Competency in data capture, reporting and management systems e.g. GxP data recording and archiving, sample management, and capability to train/mentor junior team members
- Competency in completing quality documentation such as SOPs, deviations, CAPAs, CC and responses to QA audit reports, and capability to train/mentor junior team members
- Good knowledge/experience of analytical instrumentation e.g. plate reader, FACS and understanding of qualification and validation procedures.
- Lead the development, troubleshooting and validation of analytical methods.
- Competency to explaining clearly why an experiment is being conducted and how the experiments help the group to meet their objectives
- Good understanding of how own area of operation relates to the overall business of OXB.
- Good understanding of the overall responsibilities and objectives of TSG
- Good knowledge of the literature in defined project area
Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.
Collaborate. Contribute. Change lives
No agencies please