Bioanalytical Research Associate

Alembic Pharmaceuticals; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

Alembic Pharmaceuticals in Vadodara seeks a Bioanalytical Analyst to perform sample processing for method development, validation and study sample analysis. You will operate and maintain LC-MS/MS instruments used in bioanalytical studies and ensure compliance with GLP and SOPs.

Responsibilities include data integrity, documentation, calibration of lab instruments, and collaboration with project leaders to ensure timely completion of tasks.

Qualifications

• M.Sc. / M.Pharm or equivalent in Pharmaceutical Sciences or related field.
• Experience in bioanalytical research or bioequivalence studies preferred.
• Hands-on exposure to LC-MS/MS and bioanalytical sample processing desirable.
• Good understanding of GLP, SOPs, documentation and laboratory practices.
• Strong attention to detail, analytical thinking and commitment to data integrity.

Responsibilities

• Perform sample processing for method development, validation and study sample analysis.
• Operate and maintain LC-MS/MS instruments used for bioanalytical studies.
• Troubleshoot instrument-related issues and coordinate resolution.
• Prepare and review SOPs, protocols, worksheets and other documentation per GLP/SOP requirements.
• Perform calibration, preventive maintenance and routine checks of laboratory instruments.
• Ensure proper documentation, data integrity and compliance throughout the study lifecycle.
• Maintain and archive method validation / partial method validation and study data per procedures.
• Follow GLP, SOPs, safety and quality requirements during all laboratory activities.
• Coordinate with Project Leaders, Group Leaders and other stakeholders for timely execution of assigned activities.
• Perform any other responsibilities or assignments entrusted by the Project Leader / Group Leader / In-charge Bioanalytical.

Skills

Attention to detail

Analytical thinking

Data integrity

Documentation

GLP compliance

Education

M.Sc. / M.Pharm / equivalent in Pharmaceutical Sciences or related field

Tools

LC-MS/MS

Job description

• Perform sample processing for method development, method validation and study sample analysis.
• Operate and perform routine maintenance of LC-MS/MS instruments used for bioanalytical studies.
• Troubleshoot instrument-related issues and malfunctions and coordinate for resolution wherever required.
• Prepare and review SOPs, protocols, worksheets and other applicable documentation in accordance with GLP and established SOP requirements.
• Perform calibration, preventive maintenance and routine checks of laboratory instruments.
• Ensure proper documentation, data integrity and compliance throughout the study lifecycle.
• Maintain and perform archival of method validation / partial method validation and study-related data as per applicable procedures.
• Follow applicable GLP, SOPs, safety and quality requirements during all laboratory activities.
• Coordinate with Project Leaders, Group Leaders and other stakeholders for timely execution of assigned activities.
• Perform any other responsibilities or assignments entrusted by the Project Leader / Group Leader / In-charge Bioanalytical.

Preferred Qualifications

• M.Sc. / M.Pharm / equivalent qualification in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology or a related discipline.
• Relevant experience in bioanalytical research / bioequivalence studies will be preferred.
• Hands-on exposure to LC-MS/MS and bioanalytical sample processing is desirable.
• Good understanding of GLP, SOPs, documentation and laboratory practices.
• Strong attention to detail, analytical thinking and a commitment to data integrity.