Associate - Formulation Analytical

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

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