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