We are looking for a Analytical Stability Co-Ordinator to plan, initiate, track performance and report on Development stability studies performed at Immunocore, as well as monitoring and reporting on GMP studies at external contract sites, supporting the advancement of the Company's Product Pipeline, with adherence to the required Quality Systems.
- Oversee the planning, co-ordination and day-to-day performance of Immunocore stability studies
- Ensure that stability protocols and commitments for projects are defined and implemented, with timely delivery of reliable and trusted data.
- Support planning, design and content of future studies
- Liaise with internal groups and/or external suppliers regarding the initiation of new stability studies, as well as ongoing stability programs
- Write and Review study protocols
- Maintain sample inventories
- Oversight of controlled stability sample storage
- Oversight of the scheduling and laboratory testing by trained analysts
- Train and Perform analytical testing, if required
- Understand requirements for the suitability and maintenance of equipment used in stability studies
- Perform trending and statistical analysis
- Operate to appropriate cGMP and Immunocore QMS compliance
You will need experience of analytical testing and stability management in biopharmaceuticals. Experienced in writing study documents, including procedures (SOP's), protocols, reports.
Knowledge of method validation requirements to demonstrate stability indicating capabilities.
Familiar with requirements for ensuring data integrity of reported results. Recorded results in a concise and timely way, and in compliance with agreed standards.
Excellent organisational and communication skills both written and verbal.
You will needs a BSc, or MSc. in protein engineering, biochemistry, molecular biology or related discipline. It would also be desirable to have a PhD in a related discipline.