- 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 Positive 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
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