Job description

QC Stability Scientist

Immunocore, UK

QC Stability Associate Scientist  (CMC)
Immunocore, UK

Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.

It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.

 

KEY RESPONSIBILITIES

  • Support, and input to, established and evolving GMP and Quality driven processes for ensuring data integrity of results being generated and reported from the Quality Control functional area
  • Operate in compliance to the defined Immunocore Quality management Systems
  • Support compilation of QC testing metrics to drive method and quality improvements
  • Complete training and demonstrate competence in the portfolio range of Analytical stability test methods
  • Perform Stability Testing for Development studies, or other related test method performance within Quality requirements, across Immunocore projects
  • Execute test methods in accordance and compliance with documented SOPs
  • Document testing in compliance with local procedures, forms and templates
  • Conduct technical and Quality reviews of testing records
  • Report and own unexpected result, invalid test, and non-conformance investigations
  • Ensure data integrity of reportable results, including data transcription across documents
  • Perform trending and statistical analysis
  • Compile reports
  • Write SOPs as required
  • Train Quality Control analysts in stability test methods and Quality expectations
  • Prioritise activities and manage the timely delivery of Quality approved stability results
  • Ensure all work and documentation is performed to a consistently high level of accuracy and compliance
  • Control sample management for stability studies within related quality systems
  • Oversight of controlled stability sample storage
  • Understand requirements for the suitability and maintenance of equipment used in stability studies
  • Support planning, design and content of stability studies
  • Stay up to date with ICH and relevant regulatory guidelines
  • Write and Review stability protocols
  • Support the preparation of regulatory documents

 

EXPERIENCE AND KNOWLEDGE

 

Essential 

  • Proven experience (1-3 years) of analytical method Quality Control testing and working to GMP compliance
  • Knowledge of stability study design, testing requirements and related ICH / other regulatory guidelines
  • Performing methods in compliance with SOPs
  • Understanding of system suitability criteria and assay acceptance criteria for assessing test validity
  • Familiar with established documentation practices for stability programs
  • Experienced in writing study documents, including protocols & reports.
  • Working to QMS procedures and documenting Quality events (e.g. OOS, NCs)
  • Pro-actively contributed to maintaining and enhancing GMP and quality working practices
  • Familiar with requirements for ensuring data integrity of reported results
  • Recorded results in a concise and timely way, and in compliance with agreed standards
  • Understanding of analytical requirements to support clinical and commercial products

 

EDUCATION & QUALIFICATIONS

  • Essential: BSc. Or MSc. in protein engineering, biochemistry, molecular biology or related discipline
  • Desirable: PhD in related discipline

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