The successful candidate will play a key role in developing, optimizing, qualifying, and deploying robust RP-U(H)PLC and SEC-U(H)PLC analytical methods for antigen content determination and characterization in drug substance samples. This position offers the opportunity to contribute to cutting-edge biopharmaceutical development while collaborating closely with internal stakeholders’ teams.
Key Responsibilities
- Method Development & Optimization
- Design and execute experiments for RP-U(H)PLC and SEC-U(H)PLC methods, including column and mobile phase screening, gradient optimization, and sample preparation.
- Fine-tune chromatographic parameters to ensure antigen integrity, recovery, and accurate quantification.
- Performance & Robustness Studies
- Assess method accuracy, precision, linearity, sensitivity, and specificity.
- Conduct robustness studies by varying critical parameters to establish operating ranges and control limits.
- Documentation & Reporting
- Draft comprehensive Method Development Reports (MDRs), protocols, and technical input documents.
- Generate raw data packages, summary reports, and interim progress presentations for project teams.
- Technical Transfer & Training
- Support initial routine testing, troubleshooting, and knowledge transfer activities.
Deliverables
- Final approved RP-U(H)PLC and SEC-U(H)PLC protocols and MDRs.
- Qualified methods ready for routine developmental and QC use.
- Training records confirming successful knowledge transfer.
- Comprehensive handover documentation and project summary reports.