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 solid 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 Develo

📌 Vaccines - r&d (analytical development) (Hyderabad)
🏢 Biological E
📍 Hyderabad