Job Title: Research Associate – Bioanalytical Operations
Job ID: 1362
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
CTC Range: INR 3 – 5 Lacs per annum
Company Overview
Lambda Therapeutic Research Ltd. is a full-service global Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations across India, USA, Canada, Poland, and the UK. The organization delivers comprehensive clinical research, bioanalytical, and regulatory services to innovator, biotechnology, and generic pharmaceutical companies worldwide.
Job Summary
Lambda Therapeutic Research Ltd. is seeking a Research Associate – Bioanalytical Operations to support bioanalytical method development, validation, and sample analysis in a regulated laboratory environment. The role requires hands-on expertise in LC-MS/MS instrumentation, strong knowledge of GLP compliance, and adherence to 21 CFR Part 11 and OECD GLP principles.
This opportunity is ideal for pharmaceutical and life sciences professionals looking to build or advance their career in bioanalytical research within a global CRO setting.
Key Responsibilities
Bioanalytical Method Development & Validation
Develop and validate bioanalytical methods as per regulatory and protocol requirements.
Process and analyze biological samples for assigned clinical and bioequivalence projects.
Instrumentation & Technical Operations
Operate, calibrate, and troubleshoot LC-MS/MS and other analytical instruments.
Ensure proper maintenance and documentation of instrument usage and performance.
Regulatory Compliance & Documentation
Prepare draft method SOPs and adhere to system-specific and method-specific SOPs.
Complete mandatory SOP and document training prior to initiating project-related activities.
Ensure strict implementation of GLP, OECD GLP principles, and 21 CFR Part 11 compliance.
Verify instrument labels, maintain equipment logbooks, and ensure timely instrument calibration.
Maintain data integrity and audit readiness across all laboratory operations.
Educational Qualification
M.Pharm, M.Sc., or B.Pharm in a relevant Life Sciences discipline.
Experience Required
3 to 5 years of hands-on experience in bioanalytical laboratory operations within a CRO, pharmaceutical, or regulated research environment.
Practical experience in LC-MS/MS method development and validation is essential.
Core Competencies
Bioanalytical Method Development
LC-MS/MS Operation & Troubleshooting
GLP & OECD Compliance
21 CFR Part 11 Documentation Standards
Clinical & BA/BE Sample Analysis
Regulatory Audit Preparedness
SEO & GEO Optimized Keywords
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Why Join Lambda Therapeutic Research Ltd.
Lambda offers professionals the opportunity to work on global clinical and bioequivalence studies in a structured, compliance-driven CRO environment. This role provides exposure to advanced analytical technologies, regulatory frameworks, and international research standards within the pharmaceutical and biotechnology sectors.
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