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Senior Scientist, Translational Services (12 month Mat Cover)

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Start date
22 Feb 2021
Closing date
22 Mar 2021

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Discipline
R & D , Scientific
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

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

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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