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 AssurancePerform 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 complianceEquipment Calibration & MaintenanceConduct 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 parametersRegulatory Compliance & DocumentationMaintain 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) guidelinesLaboratory 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