About this role
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-MSEnsure 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 techniquesGenerate 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 protocolsMaintain 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 standardsPrepare and develop study protocols and Standard Operating Procedures (SOPs) to ensure consistency and regulatory adherenceMaintain 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 standardsCollaborate 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 disciplineMinimum 3-4 years of professional experience in analytical chemistry, pharmaceutical formulation analysis, or related laboratory environmentDemonstrated expertise in analytical instrumentation, including HPLC-UV, GC, LC-MS/MS, and ICP-MSComprehensive knowledge of regulatory compliance standards, including GLP and GMP guidelinesProficiency in analytical method development, validation, and documentation in accordance with regulatory requirementsStrong technical competency in data management and regulatory documentation practicesPreferred:
Experience with IND submissions and preclinical analytical supportFamiliarity with pharmaceutical quality assurance protocols and Certificate of Analysis (CoA) preparationProven track record of maintaining compliance with regulatory standards in a pharmaceutical or contract research organization (CRO) setting