Bioanalytical Monitor - Sr. Executive

ExeMed; Vadodara; On-site; INR 900,000 - 1,300,000; Full time

Job summary

$ExeMed$ in India is seeking a bioanalytical professional to oversee method development, validation, and study sample analysis in line with SOPs and regulatory standards. You will operate HPLC/LC-MS, review data, and ensure timely CRO collaboration under GLP guidelines.

The role involves coordinating with clinical sites for sample shipments, reviewing SOPs and study reports, and ensuring audit findings are addressed with guidance from management.

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.

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.