Job Title: Research Associate – Bioanalytical Operations
Location: Ahmedabad, India
Summary:
Lambda Therapeutic Research, a leading global Contract Research Organization (CRO), is seeking a highly motivated and experienced Research Associate to join our Bioanalytical Operations team in Ahmedabad. This role offers an exciting opportunity to contribute to bioanalytical method development, sample analysis, and LC-MS/MS operations within a GLP-compliant environment. If you possess a strong understanding of bioanalytical workflows, regulatory requirements, and have a passion for advancing your career in the field of bioanalysis, we encourage you to apply.
About Lambda Therapeutic Research:
Lambda Therapeutic Research is a globally recognized CRO providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device companies. We are committed to scientific excellence, regulatory compliance, and delivering high-quality data to support the development of innovative healthcare products. Joining Lambda means becoming part of a dynamic and collaborative team dedicated to making a positive impact on global health.
Job Description:
As a Research Associate in Bioanalytical Operations, you will be responsible for supporting the development, validation, and execution of bioanalytical methods for pharmacokinetic (PK) and pharmacodynamic (PD) studies. You will work under the supervision of senior scientists and contribute to all aspects of bioanalytical operations, from sample preparation to data analysis and reporting. This role requires a strong understanding of GLP principles, proficiency in LC-MS/MS operations, and a commitment to maintaining accurate and reliable data.
Key Responsibilities:
- Develop and validate bioanalytical methods as per project requirements, ensuring compliance with regulatory guidelines and standard operating procedures (SOPs).
- Process and analyze biological samples (e.g., plasma, serum, urine) for assigned studies, following established protocols and quality control procedures.
- Operate, calibrate, and troubleshoot LC-MS/MS instruments (e.g., Sciex, Thermo Scientific) and other analytical equipment.
- Prepare method SOPs, draft procedures, and ensure compliance with protocol and system SOPs.
- Complete all mandatory training programs before initiating any activities, demonstrating a commitment to continuous learning and professional development.
- Implement GLP and 21 CFR Part 11 requirements, including meticulous documentation, equipment labeling, and calibration tracking.
- Adhere strictly to OECD GLP principles in all aspects of work, ensuring the integrity and reliability of data.
- Contribute to the maintenance of a clean and organized laboratory environment.
- Participate in data review and contribute to the preparation of study reports.
- Effectively communicate results and challenges to senior scientists and project managers.
Required Qualifications:
- M.Pharm / M.Sc / B.Pharm degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmacology).
- 3 to 5 years of hands-on experience in bioanalytical method development, LC-MS/MS operations, and regulated laboratory environments.
- Strong understanding of GLP, regulatory expectations (e.g., FDA, EMA), and bioanalytical workflows.
Skills & Competencies:
- Proficiency in LC-MS/MS handling and troubleshooting, including experience with various instrument platforms and software.
- Knowledge of method validation parameters, including selectivity, sensitivity, accuracy, precision, and stability.
- Strong documentation skills and a compliance-oriented mindset.
- Understanding of 21 CFR Part 11 requirements for electronic records and signatures.
- Ability to work under strict timelines in a regulated CRO setting, demonstrating excellent time management and organizational skills.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
- Problem-solving skills and the ability to identify and resolve technical issues.
- A strong commitment to quality and accuracy.
Benefits of Joining Lambda Therapeutic Research:
- Work with a world-class global CRO with advanced analytical technologies and state-of-the-art facilities.
- Exposure to regulated markets (US, Canada, Europe), providing valuable experience in global bioanalytical practices.
- Opportunity to work on innovative projects and contribute to the development of new therapies.
- Career growth opportunities in bioanalytical and clinical research domains, with opportunities for advancement within the organization.
- Competitive CTC: INR 3,00,000 – 5,00,000 per annum, commensurate with experience and qualifications.
- Comprehensive benefits package including health insurance, paid time off, and other employee benefits.
How to Apply:
If you are a qualified and enthusiastic individual seeking a challenging and rewarding career in bioanalytical operations, we encourage you to apply. Please submit your resume and cover letter highlighting your relevant experience and qualifications.