Sr. Scientist 1

Aurigene; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Aurigene Oncology Limited, Bangalore, is seeking an experienced professional for analytical development and QC leadership. You will oversee method development, validation, and transfer for OSD, injectables, and liposomal formulations with GLP-compliant practices.

Role emphasizes regulatory-driven stability, advanced solid-state characterization, QMS management, and training capabilities. Collaboration with external labs and auditors is required to ensure compliant, high-quality testing.

Qualifications

• Oversee method development, validation and transfer for various dosage forms.
• Design and execute regulatory-driven stability studies per global standards.
• Perform advanced solid-state characterization using spectroscopy and thermal tools.
• Maintain GLP and audit-readiness in the lab.
• Manage QMS workflows including investigations and CAPAs.
• Conduct technical training on analytics instrumentation and SOPs.
• Coordinate with vendors, contract labs and auditors for external testing.

Responsibilities

• Oversee method development, validation, and transfer for OSD, Injectables, and long-acting formulations.
• Design, execute, and monitor stability studies per global regulatory requirements.
• Perform and interpret advanced analyses using spectroscopic techniques, PXRD, DSC, TGA, Zetasizer.
• Maintain GLP and ensure audit-readiness and laboratory compliance.
• Actively manage QMS workflows including investigations, deviations, change controls, CAPAs.
• Conduct technical training sessions for analytical instrumentation and SOPs.
• Coordinate with vendors and contract testing laboratories for external testing and outsourcing.

Skills

Analytical method management

Regulatory stability studies

Solid-state characterization

GLP & lab compliance

QMS management

Training & capability building

External coordination

Education

M.Pharm

M.Sc

Tools

PXRD

DSC

TGA

Zetasizer

Job description

Posted On 16 Sep 2026

End Date 30 Sep 2026

Required Experience 10 - 12 years

• Aurigene Oncology Limited>Aurigene Oncology Limited - Bangalore>Early Development>Quality Control>Quality Control>103379>91011103

M Pharm M.Sc

Job Description

• Analytical Method Management : Oversee method development, validation, and transfer for OSD, Injectables, and long-acting formulations—with a strong 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 Good 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.