Scientist IV ASG

We are currently recruiting for a Scientist IV to join the Analytical Development and QC team. The purpose of this role is to plan, execute and report laboratory-based experiments or analytical investigations in accordance with scientific or regulatory requirements, in alignment with department objectives. Our Analytical Development and QC Group supports the development of products through analytical testing to facilitate manufacturing, shelf life setting and process development, ensuring appropriate quality controls and use of analytics. Our Darwin team performs lab-based analytical assays (Flow Cytometry, qPCR, ELISA, Tissue culture, and Gel electrophoresis) to provide analytical support for QC batch release as well as development and investigational,

• Accountable for own performance in alignment with group objectives and deadlines. Design and conduct experiments /investigations in accordance with correct methodologies and procedures under the direction of the Team Lead.
• Ensure a high standard of record keeping and documentation of experiments and investigations in order that information is clearly captured and disseminated and reported.
• Act as Subject Matter Expert (SME) for Analytical assays and present scientific data at internal meetings
• Perform analytical testing as part of QC release and stability.
• Timely and accurate completion of GxP paperwork.
• Perform analytical testing as part of validation of analytical methods
• Will report to the Team Lead.
• Identifying and document non-conformances (OOS, OOE, CC)
• Conduct research and technical support of the highest quality, largely in a single project area but will assist in other projects as the need arises.
• May be responsible for maintenance of a laboratory area and/or important equipment.
• Personally responsible for the completion of tasks in relation to their criticality.
• Joint responsibility for maintenance and compliance of a GxP laboratory area and GxP "housekeeping" procedures.
• Work will be conducted in accordance with the OXB quality management system.
• Writing and reviewing of departmental documentation and SOP's.
• Preparation of reports and documents to support GxP and regulatory activities.
  
  Minimum BSc Degree programme level with relevant experience
• Where required a detailed knowledge and experience of GxP
• Knowledge in Virology and gene therapy would be an advantage
• Laboratory technical experience with particular emphasis on Flow Cytometry and one or more of the following: Tissue Culture, qPCR Molecular Biology and protein chemistry
• Experience in using MS Word, Excel, PowerPoint & Outlook & Teams.
• Demonstrate competency in performing laboratory tasks and general experimental procedures with expertise in one or more areas.
• Trained to operate equipment in accordance with OXB procedures and requirements. Responsibility for a single piece of equipment and the ability to troubleshoot.
• Expertise in the use of complex instrumentation eg qPCR, Flow Cytometry or using difficult biological procedures that requires a specialist knowledge or skill.
• Understanding of laboratory health and safety requirements.
• Understanding of Laboratory Information Management Systems (LIMS)
• Sufficient understanding of the overall activities in the department to contribute useful ideas at meetings.
• Capable of interpreting results from experiments and drawing conclusions but may need guidance from senior scientists.
• Capable of explaining clearly the scientific background of an assay as well as train more junior staff members.
• Good knowledge of regulatory requirements e.g. GMP, GLP, GCP and/or Validation and Quality Management systems.
• Detailed knowledge of regulatory requirements e.g. GMP, GLP, GCP and/or Validation and Quality Management systems.
• Detailed knowledge of the Quality management reporting structure/responsibilities within OXB.
• High regard for safety and display a high level of good laboratory citizenship.
• Detailed knowledge of the regulatory requirements for analytical work (e.g. product specifications, stability testing guidelines etc) is required.
• Highly motivated and enthusiastic.
• Ability to work well in a team.
  
  OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.
OXB 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. OXB'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. What's in it for you:
• Highly competitive total reward packages
• Wellbeing programmes
• Development opportunities
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Responsible, Responsive, Resilient, Respect
• State of the art laboratory and manufacturing facilities
We want you to feel inspired every day. We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.