QC Analytical Scientist
On-siteStevenage, England, United Kingdom
Job Summary
Execute routine and release testing for drug product samples using validated methods including ddPCR, sterility, endotoxin, and flow cytometry. Manage QC materials, prepare reagents, and maintain laboratory instruments per SOPs while ensuring inspection-ready conditions. Lead minor quality events, conduct root cause analysis, and implement corrective and preventive actions for deviations and change controls. Design GMP documentation, prepare certificates of analysis, and ensure data integrity through timely record archiving and trending. This role supports Autolus's development of T cell therapies for cancer and autoimmune diseases. Shift-based hours rotate between Sunday–Wednesday and Wednesday–Saturday.
Required Qualifications
- Minimum 5 years' experience within a QC laboratory, without BSc/MSc degree in life sciences
- Minimum 2 years' experience within a QC laboratory, with BSc/MSc degree in life sciences
- No minimum industry experience, with a PhD in life sciences or relevant subject
- BSc/MSc degree in life sciences or significant relevant industry experience
- Soft skills (effective written and spoken communication, organisation, teamwork)
- Ability to precisely follow instructions and procedures
- Open to working shifts
- Attention to detail
- Meet requirements to work in cleanroom environment
- Good technical writing skills
- Detailed understanding of the assay or test principles, including pharmacopeial monographs and regulatory guidance
- Good knowledge of statistics (calculation of mean, median, standard deviation, %CV), interpretation of statistical analysis results (e.g., t-test, confidence intervals)
- Reporting of numerical values – significant figures, decimal places, rounding in the context of generating and reporting results
- Understanding of method performance parameters (e.g., precision, accuracy, linearity, range, LOQ, LOD)
- Working knowledge of aseptic technique and cell culture methodology
- Good understanding of principles of analytical instrumentation used in the QC laboratory
Desired Qualifications
- Good knowledge of statistics (calculation of mean, median, standard deviation, %CV), interpretation of statistical analysis results (e.g., t-test, confidence intervals)
- Understanding of analytical method validation, verification and tech transfer process
- Familiarity with relevant regulations governing Quality Control function (e.g., EudraLex, ICH, FDA CFR)
- Working knowledge of Quality Management System records (e.g., deviation, CAPA, laboratory investigation, change control)
- Experience in LIMS
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