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