Accelerate Drug Development as a Bioanalytical Research Associate
Drive Precision & Compliance in a Global CRO Laboratory
Lambda Therapeutic Research is a leading global Clinical Research Organization (CRO) dedicated to advancing human health through rigorous science. With our headquarters in Ahmedabad and a strategic international presence, we deliver comprehensive, end-to-end research services. We are expanding our Bioanalytical Operations team and seek a skilled Research Associate to ensure the highest standards of analytical excellence in support of global drug development programs.
Key Responsibilities
Method Development & Validation
- Develop and validate robust, compliant bioanalytical methods (e.g., LC-MS/MS) to support preclinical and clinical studies.
Sample Analysis & Instrumentation
- Accurately process and analyze biological samples for allotted projects, ensuring data integrity and timely delivery.
- Operate, perform routine calibration, and assist in troubleshooting advanced analytical instruments, with a focus on LC-MS/MS systems.
Documentation & Quality Compliance
- Prepare method-specific Standard Operating Procedures (SOPs), draft protocols, and related technical documents.
- Work in strict compliance with all System/Method SOPs, relevant study plans/protocols, and regulatory guidelines.
- Ensure all required SOPs and documents are reviewed and trained on prior to initiating project activities.
Laboratory Quality Systems & GLP
- Actively support laboratory compliance with Good Laboratory Practice (GLP), 21 CFR Part 11, and OECD GLP principles.
- Maintain instrument logs, check calibration status and labels, and ensure all equipment calibrations are performed before their due dates.
Qualifications & Experience
Essential Requirements:
- M.Pharm, M.Sc., or B.Pharm in a relevant pharmaceutical or life sciences discipline.
- 3 to 5 years of direct hands-on experience in a bioanalytical laboratory within a CRO, pharmaceutical, or biotech setting.
- Proven, practical experience in LC-MS/MS method development, validation, and sample analysis for biological matrices.
- Strong operational knowledge of LC-MS/MS instrumentation and other relevant analytical equipment.
- Working knowledge of GLP, 21 CFR Part 11, and OECD principles.
- Excellent attention to detail, documentation skills, and a commitment to data quality.
Preferred Attributes:
- Experience in a regulated GLP/GCP environment supporting regulatory submissions.
- Familiarity with electronic laboratory notebooks (ELN) and Laboratory Information Management Systems (LIMS).
- Demonstrated ability to troubleshoot instrument-related issues.
- Effective organizational and communication skills for collaborative teamwork.
Why Build Your Career in Our Bioanalytical Team?
- Critical Impact: Generate pivotal pharmacokinetic and toxicokinetic data that directly influences drug development decisions for global clients.
- Technical Mastery: Work with state-of-the-art instrumentation in a high-compliance environment, deepening your expertise in regulated bioanalysis.
- Structured Growth: Clear career progression pathway within Bioanalytical Operations, from Research Associate to Senior Scientist and team leadership roles.
- Global Standards: Develop your skills within a world-class quality system that meets international regulatory expectations.
- Collaborative Science: Integrate with a team of dedicated scientists and cross-functional project teams in a supportive, science-driven culture.
Ready to apply your analytical expertise to advance global therapeutics?
Apply now for the Bioanalytical Research Associate position in Ahmedabad.
Lambda Therapeutic Research is an equal opportunity employer. We foster a diverse and inclusive workplace where scientific integrity and professional growth go hand in hand.
