Associate - Formulation Analytical

Key Responsibilities

Analytical Method Development & Validation

**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

Responsibilities

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

Requirements

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

Nice to have

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