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Analytical Development and Technology Specialist

2 months ago

Oxford, Oxfordshire, United Kingdom Oxford Biomedica Full time

Oxford Biomedica is a leading viral vector Contract Development and Manufacturing Organization (CDMO) with over 25 years of experience in cell and gene therapy. We are currently recruiting for an Analytical Development and Technology Specialist to join our team.

About the Role:

This is an office-based role that requires controlling assay life cycle from development to QC in accordance with scientific and regulatory requirements. The successful candidate will work closely with the Analytical Services and Quality Control department to ensure high-quality analytical testing, manufacturing, and process development.

Key Responsibilities:

  • Management and justification of assay acceptance criteria
  • Management of in-house control materials, including qualification studies to ensure fit-for-use
  • Assisting in the development and transfer of assays when required
  • Assist with investigations in accordance with correct methodologies and procedures under the direction of Subject Matter Expert/QC Manager/Line Manager
  • Ensuring a high standard of record keeping and documentation of assays and investigations
  • Presentation of scientific data at internal meetings
  • Involvement in Analytical method transfer
  • Responsible for the completion of tasks about their criticality
  • Work will be conducted in accordance with the OXB Quality Management system
  • Writing and reviewing of departmental documentation and SOPs
  • Completion of Quality records (Change control, Deviation, and CAPAs) to a high level in a timely manner

What You'll Need:

  • Educated to a minimum of BSc Degree with basic experience of working in a related environment
  • An understanding of Virology and gene therapy would be an advantage
  • Technical experience in cell culture, qPCR or molecular biology
  • Proven abilities in critical thinking and trouble-shooting
  • Experience of working under regulatory requirements, e.g. GMP, GLP, GCP and/or Validation and Quality Management systems
  • Good working knowledge of Excel
  • Working knowledge of JMP and/or Minitab an advantage

Salary Estimate: £55,000 - £65,000 per annum, depending on experience.

About Us:

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. Our capabilities span from early-stage development to commercialisation, supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.

Benefits:

  • Highly competitive total reward packages
  • Wellbeing programmes
  • Development opportunities
  • Welcoming, friendly, supportive colleagues
  • A diverse and inclusive working environment
  • State of the art laboratory and manufacturing facilities