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

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

Associate - Formulation Analytical

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