Function : R&D - Analytical

BU : Vaccines

Job location : Genome Valley, Shamirpet, Hyderabad

Candidate Preferred Industry : Biologics/Vaccines/Biopharma

Job Responsibilities / Summary:

• Lead the planning, execution, monitoring, and reporting of stability studies for drug substances and drug products in compliance with regulatory requirements.
• Ensure adherence to global regulatory guidelines including ICH, FDA, EMA and other applicable standards.
• Supervise, guide, and mentor analytical team members while fostering a culture of quality, compliance, collaboration, and accountability.
• Review, interpret, and trend analytical and stability data, prepare technical reports and provide support for regulatory submissions and audits.
• Collaborate closely with cross-functional teams including QA, QC, R&D Manufacturing, and Regulatory Affairs to support product development and lifecycle acti...