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
Qualifications
- ✓Master's degree (M.Sc. or M. Pharm.) in Chemistry, Pharmaceutical Sciences, or related discipline
- ✓Minimum 3-4 years of professional experience in analytical chemistry, pharmaceutical formulation analysis, or related laboratory environment
- ✓Demonstrated expertise in analytical instrumentation, including HPLC-UV, GC, LC-MS/MS, and ICP-MS
- ✓Comprehensive knowledge of regulatory compliance standards, including GLP and GMP guidelines
- ✓Proficiency in analytical method development, validation, and documentation in accordance with regulatory requirements
- ✓Strong technical competency in data management and regulatory documentation practices
Preferred
- ✓Experience with IND submissions and preclinical analytical support
- ✓Familiarity with pharmaceutical quality assurance protocols and Certificate of Analysis (CoA) preparation
- ✓Proven track record of maintaining compliance with regulatory standards in a pharmaceutical or contract research organization (CRO) setting