_{07th April, 2026}

Summary
 
We are seeking a Scientist II - Biology/Microbiology to perform laboratory testing and analysis in support of raw materials, drug substances, and finished products. This role ensures compliance with regulatory standards (cGMP) and supports quality, validation, and environmental monitoring activities.
 
Responsibilities

• Perform laboratory analyses including, but not limited to:
• Microbial Purity Testing
• Bacterial Endotoxin Testing
• Biological Indicators certification and analysis
• Environmental monitoring and utilities testing
• Execute testing for raw materials, drug substances, and finished products in compliance with internal procedures and regulatory requirements.
• Follow laboratory schedules for:
• Raw material testing
• Product testing
• Environmental monitoring
• Utilities and special projects
• Conduct water sampling and analysis, maintain trend data, and support:
• Method validation
• Process validation
• Cleaning validation and trend analysis
• Identify microbial growth and perform microbiological identification.
• Ensure all activities comply with cGMP practices and internal quality policies.
• Prepare culture media, reagents, and stock cultures as required, including:
• Media preparation
• Growth promotion testing
• Support investigations, deviations, and manufacturing-related issues.
• Ensure laboratory equipment is:
• Qualified
• Calibrated
• Maintained in proper working condition
• Verify all materials and culture media are approved and within expiration date prior to use.
• Operate laboratory instruments such as:
• Autoclaves
• pH meters
• Microscopes
• Analytical balances
• Microbial identification systems (manual and automated)
• Computerized laboratory systems

Requirements

• Bachelor's Degree in Biology, Microbiology, or a related scientific field
• Experience in pharmaceutical or biotech industry
• Knowledge of cGMP regulations
• Experience with environmental monitoring and microbiological techniques

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