Associate - Formulation Analytical

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