22 Sep
|
Aurigene Oncology
|
India
22 Sep
Aurigene Oncology
India
Analytical Method Management: Oversee method development, validation, and transfer for OSD, Injectables, and long-acting formulations—with a robust emphasis on liposomal formulations and nano-suspensions.
Regulatory-Driven Stability Studies: Design, execute, and monitor stability studies in strict alignment with global regulatory requirements.
Advanced Solid-State Characterization: Perform and interpret complex analyses using spectroscopic techniques, PXRD, DSC, TGA, Zetasizer, and other physical characterization tools.
Lab Compliance & GLP: Maintain rigorous Positive Laboratory Practices (GLP) and ensure continuous audit-readiness and laboratory compliance.
Hands-on QMS Management: Actively manage and execute Quality Management System (QMS) workflows, including investigations, deviations, change controls, and CAPAs.
Training & Capability Building: Conduct technical training sessions for the team on analytical instrumentation, SOPs, STPs, and equipment operations.
External Coordination & Outsourcing: Coordinate seamlessly with vendors, contract testing laboratories, and auditors to manage external analytical testing, compliance, and outsourcing activities.
📌 Sr Scientist 1 Bengaluru (India)
🏢 Aurigene Oncology
📍 India