Vaccines - R&D (Analytical Development)

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 activities.
• Possess strong knowledge and hands-on experience in Quality Management Systems (QMS) including Change Controls, OOS, OOT investigations, deviations and CAPA management.
• Prepare and review analytical documentation including STPs, SOPs, protocols, specifications, and method-related documents for analytical instruments and techniques.
• Demonstrate expertise in handling and troubleshooting chromatographic and spectroscopic instruments.
• Have sound understanding and practical exposure to immunoanalytical techniques such as ELISA, Radioimmunoassay (RIA), Immunoprecipitation, Agglutination assays and Chemiluminescence Immunoassay (CLIA).
• Ensure accurate and compliant documentation practices including:
• Preparation and review of SOPs, stability protocols, and stability summary reports.
• Maintenance of laboratory notebooks and records in compliance with GMP/GLP requirements.
• Preparation of technical presentations and scientific summaries as required by management.
• Support continuous improvement initiatives, laboratory compliance, data integrity and operational excellence within the Analytical Development function.