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2-3 years
INR 4 LPA – 5 LPA
Ahmedabad, India
1 July 2, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Research Associate – Bioanalytical Operations

Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, Gujarat, India
Department: Bioanalytical Operations
Job Type: Full-Time
Experience: 2–3 Years


JOB OVERVIEW

The Research Associate – Bioanalytical Operations is responsible for developing and validating bioanalytical methods, processing and analyzing biological samples, operating and maintaining LC-MS/MS and other analytical instruments, and ensuring compliance with GLP, OECD GLP, 21 CFR Part 11, and laboratory quality standards. The role supports bioanalytical studies by performing method development, instrument calibration, documentation, SOP preparation, and laboratory operations while maintaining data integrity and regulatory compliance.


KEY RESPONSIBILITIES

Bioanalytical Method Development

  • Develop bioanalytical methods.

  • Validate analytical methods.

  • Optimize analytical procedures.

  • Prepare method validation protocols.

  • Support method transfer activities.

  • Maintain method documentation.

Sample Processing & Analysis

  • Process biological samples.

  • Analyze study samples.

  • Perform quantitative bioanalysis.

  • Ensure sample integrity.

  • Review analytical results.

  • Maintain analytical records.

  • Meet project timelines.

Instrument Operation

  • Operate LC-MS/MS systems.

  • Operate analytical instruments.

  • Perform instrument calibration.

  • Conduct routine maintenance.

  • Troubleshoot instrument issues.

  • Verify instrument performance.

  • Maintain equipment logbooks.

Documentation & SOP Management

  • Prepare draft SOPs.

  • Update method-specific SOPs.

  • Follow laboratory SOPs.

  • Maintain laboratory documentation.

  • Record analytical observations.

  • Ensure documentation accuracy.

  • Maintain audit-ready records.

Quality & Regulatory Compliance

  • Ensure compliance with GLP.

  • Follow OECD GLP principles.

  • Comply with 21 CFR Part 11 requirements.

  • Verify instrument labels.

  • Maintain calibration schedules.

  • Review equipment logbooks.

  • Ensure data integrity.

  • Follow laboratory quality standards.

Training & Laboratory Support

  • Complete mandatory SOP training.

  • Ensure training compliance before project activities.

  • Support laboratory operations.

  • Follow safety procedures.

  • Maintain laboratory cleanliness.

  • Coordinate with laboratory teams.

Project Execution

  • Execute assigned bioanalytical projects.

  • Meet project timelines.

  • Ensure high-quality analytical output.

  • Support study deliverables.

  • Report project progress.


EDUCATIONAL QUALIFICATIONS

Required

  • B.Pharm

  • M.Pharm

  • M.Sc. (Life Sciences/Chemistry/Biotechnology/Biochemistry or related discipline)


EXPERIENCE REQUIREMENTS

Required

  • 2–3 years of experience in Bioanalytical Operations.

  • Experience in LC-MS/MS analysis.

  • Experience in bioanalytical method development and validation.