Vaccines - R&D (Analytical Development)
B
Biological E. Limited
📍 Hyderabad, Telangana, India
Job Description
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 Managem...
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 Managem...