Key Responsibilities
Analytical Method Development & Validation
- Develop, optimize, and validate analytical methods for New Chemical Entities (NCEs) and generic compounds using advanced instrumentation including HPLC-UV, GC, LC-MS/MS, and ICP-MS
- Ensure all methods meet regulatory requirements and are suitable for intended applications
**Preclinical Analysis & Quality Assurance**
- Perform dose verification analysis on preclinical dose formulation samples utilizing HPLC-UV, GC, and LC-MS/MS techniques
- Generate Certificates of Analysis (CoA) for Investigational New Drug (IND) submissions with accuracy and attention to regulatory compliance
**Equipment Calibration & Maintenance**
- Conduct routine calibration and maintenance of laboratory equipment including HPLC systems, pH meters, analytical balances, and pipettes in accordance with established protocols
- Maintain detailed calibration records and ensure all instruments remain within acceptable operating parameters
**Regulatory Compliance & Documentation**
- Maintain comprehensive and secure raw data management practices in compliance with GLP/GMP standards
- Prepare and develop study protocols and Standard Operating Procedures (SOPs) to ensure consistency and regulatory adherence
- Maintain laboratory facilities and operations in full compliance with Good Laboratory Practice (GLP) guidelines
**Laboratory Operations**
- Support day-to-day laboratory operations while adhering to all quality and safety standards
- Collaborate with cross-functional teams to ensure timely completion of analytical projects