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Stability QC scientist

Oxfordshire   •  Negotiable  •  Permanent, Full time


Job Title: QC Stability Scientist

Location: Oxford, UK

Salary: Attractive salary + Benefits

** Please read **

You will be the right fit if you have the following requirements but are not limited to:

  • Full right to work in the UK
  • Working in a GMP environment
  • Proven experience in analytical method Quality Control testing.
  • Experienced in writing study documents, including protocols & reports.
  • Knowledge of stability study design, testing requirements and related ICH / other regulatory guidelines

OUR CLIENT:

CPL Life Sciences is collaborating with global biotech specialised in the development and commercialisation of new generation immunotherapies designed to treat a broad range of diseases, including cancer, infections and autoimmune diseases.

WHY THIS IS A GREAT PLACE TO WORK:

Our Client values a good life-work balance and healthy work environment, supporting a well inclusive and diverse culture where every individual is encouraged and motivated to fulfil and perform at their full potential. It is a place that allows every individual to grow and progress not only within their field of expertise but also expose them to new knowledge and experience.

THE POSITION:

This position is for a Stability QC Scientist. The successful candidate will be required to perform Quality Control analytical testing for stability studies, in compliance with GMP and related quality systems to ensure data integrity, and support related investigations, trending & reporting. This role will be part of the CMC/Drug Product Formulation and Stability team with Quality and Compliance functional systems to provide the right communication, knowledge and experience within the team.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Performing statistical analysis.
  • Assisting with the preparation of regulatory documents.
  • Stay up to date with ICH and relevant regulatory guidelines.
  • Supporting planning, design and content of stability studies.
  • Conducting technical and Quality reviews of testing records.
  • Conducting and writing reports, SOPs, stability protocols etc.
  • Executing test methods in accordance and compliance with documented SOPs.
  • Supporting compilation of QC testing metrics to drive method and quality improvements.
  • Ensuring data integrity of reportable results, including data transcription across documents.
  • Performing Stability Testing for Development studies, or other related test method performance within Quality requirements.

ESSENTIAL CRITERIA:

  • Previous experience in:

oPerforming methods in compliance with SOPs.

oWriting study documents, including protocols & reports.

oWorking on QMS procedures and documenting Quality events

oUnderstanding of system suitability criteria and assay acceptance criteria for assessing test validity

  • Knowledge of bioassays, biopharmaceutical assays, statistical evaluation of assay variability
  • Familiar with requirements for ensuring data integrity of reported results

DESIRED CRITERIA:

  • Experience with sample management.
  • Understanding of analytical requirements to support clinical and commercial products.
  • Knowledge of method validation requirements to demonstrate stability-indicating capabilities.

If you are looking for an opportunity to enhance your experience, broaden your career horizons and change the future apply today.

Georgia.Mouzouridou@cpl.com

  • Agency: Cpl Life Sciences
  • Reference: JO-2206-494235
  • Posted: 8th June 2022
  • Expires: 6th July 2022

Cpl Life Sciences

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