Associate - Formulation Analytical

Eurofins; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Eurofins Bengaluru invites an analytical chemist to join the team responsible for developing, optimizing, and validating analytical methods for NCEs and generics using HPLC-UV, GC, LC-MS/MS, and ICP-MS.

You will generate CoAs for IND submissions, ensure GLP/GMP compliance, perform preclinical analyses, and maintain calibration records while collaborating with cross-functional groups.

Qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or related field
• 3–4 years of analytical chemistry/pharma lab experience
• Experience with GLP/GMP regulations
• Proficiency in method development and validation
• Experience with IND submissions or CoA preparation preferred

Responsibilities

• Develop, optimize, and validate analytical methods for NCEs and generics using HPLC-UV, GC, LC-MS/MS, and ICP-MS
• Perform dose verification analyses on preclinical samples with HPLC-UV, GC, and LC-MS/MS
• Generate Certificates of Analysis (CoA) for IND submissions with accuracy and regulatory compliance
• Calibrate and maintain HPLC systems, pH meters, analytical balances, and pipettes
• Maintain GLP/GMP compliant data and develop study protocols and SOPs
• Support day-to-day lab operations and collaborate with cross-functional teams

Skills

Analytical thinking

Method development

Documentation practices

Data management

Regulatory compliance

Education

MSc Chemistry / M Pharma (or related)

Tools

HPLC-UV

GC

LC-MS/MS

ICP-MS

Job description

Job Description

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

• 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