Vaccine Development Jobs at Biological E.Limited | Apply Now
Are you looking for Vaccine Development Jobs, Regulatory Affairs Jobs, or R&D Jobs in the biotechnology and biopharmaceutical sector? Biological E. Limited is inviting applications for exciting opportunities in Vaccines – R&D (Analytical Development) at its Genome Valley facility in Hyderabad. Candidates with experience in biologics, vaccines, and biopharma industries can join a leading vaccine manufacturer and contribute to cutting-edge vaccine development programs while working alongside industry experts.
About Biological E. Limited
Biological E. Limited is one of India’s leading vaccine and pharmaceutical companies with a strong presence in vaccine research, development, manufacturing, and commercialization. The company plays a significant role in global immunization programs and is recognized for delivering high-quality vaccines and biologics across international markets. Through continuous innovation and scientific excellence, Biological E. provides exceptional opportunities for professionals seeking Vaccine Development Jobs, Regulatory Affairs Jobs, and R&D Jobs in the biotechnology and biopharmaceutical sectors.
Job Details
- Company: Biological E. Limited
- Department: Vaccines – R&D (Analytical Development)
- Business Unit: Vaccines
- Job Location: Genome Valley, Shamirpet, Hyderabad, Telangana, India
- Employment Type: Full-Time
- Preferred Industry: Biologics / Vaccines / Biopharma
Key Responsibilities
- 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.
- 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.
Qualifications
- Candidates from the Biologics, Vaccines, or Biopharma industries are preferred.
- Strong understanding of analytical development processes within vaccine development and biopharmaceutical research environments.
- Knowledge of global regulatory standards and quality systems.
Experience
- Experience in planning and executing stability studies for drug substances and drug products.
- Hands-on experience with Quality Management Systems (QMS), Change Controls, OOS, OOT investigations, deviations, and CAPA management.
- Experience supporting regulatory submissions and audits.
- Practical exposure to analytical development activities in vaccine and biologics programs.
Skills Needed
- Strong understanding of ICH, FDA, EMA, and other regulatory guidelines.
- Expertise in chromatographic and spectroscopic instruments.
- Sound understanding and practical exposure to immunoanalytical techniques such as:
- ELISA
- Radioimmunoassay (RIA)
- Immunoprecipitation
- Agglutination Assays
- Chemiluminescence Immunoassay (CLIA)
- Technical report preparation and analytical data interpretation.
- Documentation management in GMP/GLP environments.
- Leadership, mentoring, collaboration, and communication skills.
- Regulatory Affairs support and compliance management expertise.
If you are seeking Vaccine Development Jobs, Regulatory Affairs Jobs, or R&D Jobs in the vaccines and biopharma industry, this opportunity at Biological E. Limited offers an excellent platform to advance your career in analytical development, regulatory compliance, and vaccine research while contributing to innovative healthcare solutions.
