Job description

Quality Control Stability Scientist

91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK

MAIN PURPOSE:

Perform Quality Control analytical testing for stability studies, in compliance with GMP and related quality systems to ensure data integrity, and supporting related investigations, trending & reporting. 

 

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
• Operate in accordance with the Company’s Health and Safety policies, especially within a laboratory 
environment

 

SPECIFIC RESPONSIBILITIES

Quality Function and Compliance: Consistently and enthusiastically support established Quality Control 
functional systems, communicating and sharing experience and knowledge within the team to ensure data 
integrity of the reported results. Input to related quality investigations driving their timely closure. Proactively assess and evaluate GMP Quality Control systems, procedures and performance metrics to drive 
continuous improvement opportunities through open team communication and collaboration
• Quality Testing and Data Analyses: Performance of stability testing, in accordance with GMP and 
company quality systems, ensuring data integrity of the results output for inclusion in regulatory 
documents. Perform Trending and Analyses of standards and controls to monitor method performance, 
as well as trending of stability results to further justify product shelf-life claims. Use method performance 
metrics and outcome of investigations to drive method remediation and improvements for key stability 
indicating assays.
• Stability / Technical Knowledge: sharing knowledge and experience with the wider team and, across 
departments representing the stability team both internally and externally. May also act as a mentor or 
manager to other colleagues, especially new hires, sharing scientific and company knowledge. Keeping up 
to date with regulatory guidelines relevant to the role and/or advancement in product stability 
requirements for studies on Biologics; sharing these with leaders across the Company. 
• Test Records and Documentation: ensuring that all stability test records and related QMS documents are 
accurate, completed in a timely fashion, and to required quality standards, supporting their use in 
company regulatory submissions. Support and encourage others to achieve and maintain the required 
high standard of documentation, testing performance and data integrity.
• Priorities: establishing priorities for own work and team-based projects; making decisions on prioritisation 
based on the overall goals of the team, department and project, using direct evidence and personal 
experience as guidance. 
• Communication: communication and presentation of findings and conclusions from stability studies 
supporting all company products in meetings with colleagues, senior management and partners.
• Training: ensure training is received, up to date and documented to support role. Perform and support 
training for others, as appropriate. Train and perform analytical testing to support stability studies, if 
required.
• Health & Safety: championing and helping others to understand H&S within the company, providing adhoc training as required

 

EXPERIENCE & 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
• Worked and contributed actively in a diverse team environment
• Excellent organizational and communication (verbal and written) skills

Desirable 
• Knowledge of bioassays, biopharmaceutical assays, statistical evaluation of assay variability 
• Performing stability trending and analysis
• Experience with sample management
• Understanding of analytical requirements to support clinical and commercial products
• Knowledge of method validation requirements to demonstrate stability indicating capabilities 
• Experience of forced degradation studies and Analytical characterisation supportive of demonstrating 
product stability 
• Knowledge of formulation development of Bio-pharmaceuticals
• Proposed and driven changes in working practices that have improved efficiency, supported teams 
through adoption and change
• Mentored and coached less experienced colleagues in scientific and stability related projects
• Presented at external meetings

 

EDUCATION & QUALIFICATIONS


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

 

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