Testing of pharmaceutical substances e.g. raw materials and drug substances in a GMP environment in accordance with ISL procedures and quality systems. Focus will be chromatography analysis, along with a range of other analytical techniques as required.
Key Accountabilities
- Lead and execute routine and non-routine QC testing in compliance with cGMP, regulatory requirements, and approved analytical methods.
- Serve as a technical SME for chromatographic techniques, including HPLC, UPLC, and GC, with detectors such as UV/Vis, PDA, and MS (desirable).
- Independently develop, optimize, and troubleshoot chromatographic methods, including selection of mobile phases, gradients, columns, flow rates, temperatures, and injection parameters.
- Design and execute analytical method development studies assessing specificity, robustness, linearity, sensitivity, and overall method performance.
- Lead and perform forced degradation and stability-indicating studies to demonstrate method specificity and product knowledge.
- Plan, execute, and review full analytical method validation packages in alignment with ICH Q2 (R2), including:
- Accuracy and Precision
- Specificity
- Linearity and Range
- Robustness and Ruggedness
- LOD and LOQ
- Author, review, and approve method development reports, validation protocols, validation reports, and technical justifications.
- Provide technical oversight for method transfers, analytical lifecycle management, and continuous improvement initiatives.
- Perform advanced data analysis including chromatographic integration, impurity profiling, and data trending.
- Lead or support OOS/OOT investigations, root cause analysis, and implementation of CAPAs.
- Ensure data integrity, high-quality documentation, and strict adherence to GMP, SOPs, and regulatory expectations.
- Support regulatory inspections, client audits, and internal audits as a QC representative.
Mentor and provide technical guidance to junior QC analysts as required.