Research Associate II

Responsible for formulation development of sterile injectable products, executing lab trials, and supporting scale-up activities in compliance with regulatory and cGMP guidelines.

Key Responsibilities:

• Perform formulation development of injectable dosage forms (solutions, suspensions, lyophilized products)
• Conduct pre-formulation studies , excipient compatibility, and formulation optimization
• Execute bench-scale experiments as per project plans and protocols
• Support stability studies , sample preparation, and data evaluation
• Prepare and maintain development reports, batch records, and documentation as per regulatory requirements
• Assist in technology transfer from RD to pilot/production scale
• Ensure adherence to cGMP, GLP, and data integrity practices
• Coordinate with Analytical, QA, and Production teams for project execution

Required Skills

• Knowledge of aseptic processing sterilization techniques
• Understanding of injectable excipients and formulation principles
• Familiarity with ICH, USFDA, EU regulatory guidelines
• Hands-on experience in lab equipment analytical tools
• Good documentation, problem-solving, and teamwork skills

Preferred Skills:

• Exposure to QbD concepts and formulation optimization
• Experience in lyophilization complex injectables
• Basic understanding of scale-up and technology transfer

Key Competencies:

• Strong analytical and troubleshooting skills
• Attention to detail in documentation
• Ability to work in regulated pharma environment
• Good communication and collaboration skills