Senior Scientist, Analytical Development and Technology

4 weeks ago

Oxford, Oxfordshire, United Kingdom Oxford Biomedica Full time
Scientist III Role Summary

We are seeking a highly skilled Scientist III to join our Analytical Development and Technologies Group (ADT) within Analytical Services and Quality control department (ADQC). This is an office-based role with a focus on controlling assay life cycle from development to QC in accordance with scientific and regulatory requirements.

The successful candidate will be responsible for

Our team supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics.

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
Requirements:
  • 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
About Us:

Oxford Biomedica 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.

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.

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: Deliver Innovation, Be Inspiring and Have Integrity
  • 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.

Collaborate. Contribute. Change lives

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