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2-3 years
4 to 5 Lacs
Ahmedabad, India
10 May 22, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Research Associate – Bioanalytical Operations

Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Req ID: 1213
Date: May 19, 2026
CTC Range: ₹4,00,000 – ₹5,00,000 per annum


Company Overview

Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) with operations across India, USA, UK, Canada, and Europe. The company supports end-to-end clinical research services for pharmaceutical, biotech, and generic drug development programs.


Role Summary

The Research Associate – Bioanalytical Operations is responsible for supporting bioanalytical method development, validation, and sample analysis using advanced analytical instruments such as LC-MS/MS, while ensuring compliance with regulatory and quality standards (GLP, 21 CFR Part 11, OECD guidelines).


Key Responsibilities

1. Bioanalytical Method Development & Validation

  • Develop and validate bioanalytical methods for clinical research studies

  • Ensure methods meet regulatory and study requirements


2. Sample Analysis

  • Process and analyze biological samples for assigned projects

  • Ensure accuracy, precision, and reliability of analytical results


3. Instrument Operation & Maintenance

  • Operate LC-MS/MS and other analytical instruments

  • Perform calibration, troubleshooting, and routine maintenance

  • Ensure instruments are calibrated before due dates


4. Compliance & Quality Systems

  • Follow GLP (Good Laboratory Practice) standards

  • Ensure compliance with 21 CFR Part 11 requirements

  • Adhere to OECD GLP principles

  • Maintain proper logbooks, instrument records, and documentation

  • Check instrument labeling and compliance status regularly


5. Documentation & SOP Management

  • Prepare draft SOPs and method-specific SOPs

  • Ensure adherence to system and protocol-specific procedures

  • Maintain training compliance before starting assigned work


6. Training & Operational Readiness

  • Ensure completion of required SOP training before activities

  • Support compliance readiness and quality audits


Required Qualifications

  • M.Pharm / B.Pharm / M.Sc.

  • 2–3 years of relevant experience in bioanalytical operations


Required Skills & Competencies

Technical Skills

  • Bioanalytical method development & validation

  • LC-MS/MS handling and troubleshooting

  • Sample processing and analytical workflows

  • GLP compliance and regulatory awareness

Regulatory Knowledge

  • OECD GLP principles

  • 21 CFR Part 11 compliance

  • Understanding of laboratory quality systems

Soft Skills

  • Accountability

  • Communication skills

  • Strong work ethic

  • Organizational fit

  • Attention to detail


Work Environment

  • Laboratory-based bioanalytical research environment

  • Regulatory-compliant GLP setting

  • Pharmaceutical and clinical trial sample analysis workflows


Role Level

  • Entry-to-mid level scientific role

  • Hands-on laboratory execution position

  • Focus on technical expertise rather than leadership


Career Scope

This role typically progresses into:

  • Senior Research Associate

  • Bioanalytical Scientist

  • Study Lead / Method Development Specialist

  • QA/QC or Regulatory-facing scientific roles