Perform and/or lead technical review of assays for stability, batch release, evaluation, method transfer, and characterisation studies in accordance with SOPs, protocols, and GMP principles.
Independently assess assay validity and make sound technical and quality decisions, including handling complex scenarios in a safe and compliant manner.
Interpret analytical data against study specifications, identifying trends, atypical, OOS (Out of Specification), and OOT (Out of Trend) results.
Lead and support investigations (e.g. deviations, atypical/OOS/OOT results, CAPAs, change controls, invalid assays), ensuring robust root cause analysis and timely closure.
Plan, prioritise, and deliver assigned tasks within required timelines, proactively communicating progress and escalating issues when necessary.
Collaborate with operators, study directors, managers, and cross-functional teams to complete technical reviews and ensure quality outcomes.
Provide feedback to support development of team members and act as a mentor/trainer to junior staff.
Contribute to and lead continuous improvement initiatives, promoting best practices and addressing non-compliant or inefficient processes.
Support quality records management, ensuring accurate documentation, reporting, and audit readiness.
Participate in project teams and technical discussions, and where required, act as a QC representative in customer interactions.
Support regulatory and customer audits by providing technical expertise and ensuring compliance.
Assist in the introduction, transfer, and validation of new methods and technologies.
Contribute to QC laboratory operations, including housekeeping, equipment monitoring and maintenance, and potential system ownership responsibilities.
Support scheduling and coordination of technical reviews as required.
Work collaboratively to meet business, regulatory, and customer expectations.
Perform other duties as assigned.
What we're looking for
Bachelor's or master's degree in biology, Biochemistry, Biotechnology, or related discipline (or equivalent industry experience).
Good understanding of protein stability and relevant analytical techniques.
Working knowledge of cGMP within a regulated environment.
Strong ability to interpret scientific data and make sound quality decisions.
Good organisational and time management skills, with the ability to prioritise effectively.
Proactive mindset with strong problem-solving skills and attention to quality.
