Bioanalytical Monitor - Sr. Executive

Exemed; Vadodara; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Exemed in Vadodara, Gujarat, India, seeks a bioanalytical role to review method development, validation, and study analyses in compliance with SOPs and regulatory guidelines.

You will operate HPLC and LC-MS/MS, ensure audit findings are addressed with guidance, and coordinate shipment of samples while maintaining alignment with project timelines and GLP requirements.

Responsibilities

• Review method development, validation and study sample analysis per SOPs, protocols and regulations.
• Operate key bioanalytical equipment such as HPLC and LC–MS/MS.
• Review sample analysis and data compilation in line with SOPs.
• Ensure compliance with QC/QA audit findings, with manager guidance.
• Review SOPs, bioanalytical protocols/plans, and validation reports.
• Provide reference and internal standards for method development/validation.
• Coordinate with clinical site for timely plasma/biological sample shipment.
• Ensure CRO adheres to GLP and regulatory guidelines (USFDA, EMA, DCGI).
• Maintain CRO communication to monitor study progress and timelines.
• Review and approve Bioanalytical Study Reports for regulatory standards.
• Ensure bioanalytical methods are scientifically sound and aligned with guidelines.
• Address OOS, failed runs and deviations with CRO; review raw data and chromatograms.
• Ensure all runs are reviewed and accepted per acceptance criteria.

Job description

Role & responsibilities

• Review method development, method validation and study sample analysis in compliance with applicable methods, protocols, SOPS, and regulatory guidelines.
• Operation of key bioanalytical equipment's like HPLC, and LC-MSfMS.
• Review sample analysis and compilation Of data in timely manner in line with applicable SOPS.
• Responsible for compliance to relevant audit findings from QC/QA and take appropriate actions in relation to audit findings with guidance of my Manager.
• Review of Standard Operating Procedure (SOPs), Method SOPS, bioanalytical protocols/plan, method validation reports and bioanalytical study reports.
• Provide reference standards, internal standards, and relevant compound for method development and validation.
• Coordinate with the clinical site to ensure timely shipment of plasma/biological samples to the Bioanalytical facility under required storage conditions.
• Ensure the CRO adheres to GLP and applicable regulatory guidelines (e.g., USFDA, EMA, DCGI) for bioanalytical studies).
• Maintain regular communication with the CRO to monitor Study progress and ensure alignment with project timelines.
• Review and provide final approval of the Bioanalytical Study Report, ensuring it is complete, accurate, and meets regulatory standards.
• Ensure all bioanalytical methods are scientifically sound and aligned with current regulatory guidelines.
• Address Out-of-Specifieation (OOS), failed runs, Or method deviations promptly With CRO). Review bioanalytical raw data, chromatograms, and analytical summaries.
• Ensure all runs are reviewed and accepted as per acceptance criteria.