Department: Bioanalytical Laboratory
Reports To: Head Bioanalytical

Job Summary

The Manager – Bioanalytical is responsible for managing day-to-day bioanalytical laboratory operations, ensuring timely and accurate analysis of biological samples for Bioavailability/Bioequivalence (BA/BE), pharmacokinetic, and clinical studies in compliance with GLP, GCLP, ICH, CDSCO, US FDA, and EMA guidelines.

Key Responsibilities
Manage routine bioanalytical laboratory activities, including sample analysis, method development, method validation, and data review.
Ensure compliance with GLP, GCLP, ICH, CDSCO, US FDA, EMA, and internal SOPs.
Review analytical data, validation reports, SOPs, and study documentation before final approval.
Supervise laboratory analysts and scientists, allocate work, and monitor study timelines.
Ensure proper operation, maintenance, qualification,



and calibration of LC-MS/MS, HPLC, and other laboratory instruments.
Maintain data integrity, quality control, and documentation in accordance with regulatory requirements.
Coordinate with Clinical Operations, Quality Assurance, and Project Management for timely study execution.
Support internal audits, sponsor audits, regulatory inspections, and CAPA implementation.
Qualification & Experience
M.Pharm, M.Sc., Ph.D., or equivalent in Pharmaceutical Sciences, Analytical Chemistry, Life Sciences, or a related field.
Minimum 5+ years of experience in a bioanalytical laboratory, preferably in a CRO or pharmaceutical organization.

📌 Bioanalytical Manager Kandla
🏢 Rusan Pharma
📍 Kandla