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Principal Scientist ASG

Date: 04-May-2022

Location: Oxford, GB

Company: oxfordbiom

Our employees are able to develop their careers in exciting new medical technologies, and so can you.

Oxford BioMedica’s Analytical Services Group supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics.

 

We are currently recruiting for a Principal Scientist to join the team.  The purpose of this office-based role is to work within a small team of Scientists responsible for ensuring that reported QC release and stability results are robust, accurate and scientifically sound.

 

 

 

Your responsibilities in this role would be

 

  • Lead transfer of new assays from ADG (Analytical Development Group) to ASG, ensuring that the assays are scientifically sound and fit-for-use in GMP
  • Implement updates to GMP assays used in ASG following development work or validation
  • Use scientific understanding of assays to suggest continuous improvement activities
  • Manage analytical spreadsheets required for calculation of results
  • Manage and justify assay acceptance criteria
  • Manage in-house control materials, including qualification studies to ensure fit-for-use
  • Monitor assay performance and investigate any observed trends
  • Consistently ensure GMP compliance in all areas of work, including responsibility for change controls and deviations
  • Lead thorough and timely investigation of invalid assays
  • Lead thorough and timely investigation of OOS, OOE and OOT events
  • Lead trouble-shooting any assay-related problem inhibiting the reporting of results
  • Communicate and lead discussion with clients regarding product analytics

 

 

To be successful in this role, you will have the following skills and experience:

 

  • BSc or equivalent in a relevant Bioscience with relevant experience
  • Strong technical understanding of qPCR and/or ELISA
  • Proven abilities in critical thinking and trouble-shooting
  • Proven ability to lead projects/investigations
  • Strong communication skills; experience with external stakeholders an advantage
  • Knowledge of assay development and/or validation
  • Understanding of basic statistical techniques for data analysis
  • Experience of working within a regulatory environment; GMP an advantage
  • Strong working knowledge of Microsoft Excel
  • Excellent writing skills for preparing plans and reports
  • Experience of analysis on both large and small data sets using a range of techniques to identify outliers, trends, step changes or appropriate acceptance criteria
  • Significant experience of working with bioassays an advantage
  • Working knowledge of JMP and Minitab an advantage
  • Experience of working with viral vectors such as AAV, adenovirus or lentivirus an advantage

 

 

 

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.