Assistant Manager - Formulation Development

Why This Role Matters

Formulation Development is central to transforming vaccine research into stable, safe, and effective dosage forms. In vaccine manufacturing, formulation design directly impacts product stability, immunogenicity, scalability, and regulatory acceptance. Specialized expertise in lyophilization and biologics formulation is critical to ensure product integrity throughout its lifecycle.
At Biological E. Limited, the Formulation Development leader within the Vaccines – R&D division contributes to the development and optimization of vaccine formulations, including lyophilized products, ensuring readiness for clinical and commercial manufacturing.

Job Description

Biological E Limited is hiring experienced professionals for its Vaccines – R&D department at Shamirpet. The role focuses on development of vaccine formulations, process optimization, lyophilization cycle development, and preparation of technical documentation.
The selected candidate will work on formulation strategy, stability studies, scale-up activities, and cross-functional collaboration with Analytical Development, Production, and Regulatory Affairs teams. This role requires strong scientific understanding of biologics and pharmaceutical formulation principles.

Key Features of the Role

• Leadership role in vaccine formulation development
• Exposure to lyophilization cycle optimization
• Involvement in technology transfer and scale-up
• Preparation of technical and regulatory documentation
• Collaboration across R&D and manufacturing functions
• Opportunity to work on innovative vaccine platforms

Responsibilities

• Develop and optimize vaccine formulations for stability and efficacy
• Design and execute lyophilization cycle development studies
• Conduct pre-formulation and compatibility studies
• Perform stability study planning and data interpretation
• Support scale-up and technology transfer to manufacturing
• Prepare technical reports, development protocols, and regulatory documents
• Coordinate with Analytical Development for characterization studies
• Troubleshoot formulation-related challenges
• Ensure compliance with regulatory and quality standards
• Participate in cross-functional project review meetings

Required Qualifications

• 6 to 15 years of experience in formulation development
• Strong experience in vaccine or biologics formulations preferred
• Hands-on expertise in lyophilization process development
• Experience in technical documentation and regulatory support
• Knowledge of GMP requirements for R&D and manufacturing

Educational Requirements

• Master of Pharmacy (Pharmaceutics / Biotechnology)
• Strong scientific foundation in formulation science and biologics

Experience and Skills

• Expertise in vaccine formulation strategies
• Strong understanding of freeze-drying principles and cycle design
• Knowledge of excipient compatibility and stability assessment
• Experience in scale-up and technology transfer processes
• Excellent technical writing and documentation skills
• Analytical thinking and problem-solving capability
• Strong coordination and project management skills
• Ability to mentor junior team members (for Manager/Sr. Manager level)

Salary Insights

• Compensation aligned with experience and managerial level
• Competitive industry package for mid to senior R&D roles
• Exposure to advanced vaccine development programs
• Leadership growth within Vaccines – R&D division

Location Details

Department: Vaccines – R&D
Function: Formulation Development
Location: Shamirpet, Hyderabad

Company Overview

Biological E. Limited is a leading Indian biopharmaceutical company known for its vaccines and life-saving biologics. The organization operates advanced R&D and manufacturing facilities, contributing to national and global immunization programs.
The Vaccines – R&D division focuses on innovative formulation strategies, scalable manufacturing solutions, and regulatory-compliant vaccine development.

FAQs

Q: Is vaccine formulation experience mandatory?
Vaccine or biologics experience is strongly preferred.

Q: Is lyophilization expertise required?
Yes, hands-on experience in lyophilization cycle development is essential.

Q: Will the role involve team handling?
Yes, Manager and Senior Manager levels may involve team leadership responsibilities.

Q: Does this role support regulatory submissions?
Yes, technical documentation and regulatory support are key components.

Application Tips

• Highlight vaccine or biologics formulation projects handled
• Mention lyophilization cycle development experience
• Include scale-up and technology transfer exposure
• Showcase technical writing and regulatory documentation experience
• Quantify stability studies and development milestones achieved