Group Leader - Bioanalytical Research

The Leaders Hive; Ahmedabad District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

The Leaders Hive, Bioanalytical Research & Development department, seeks a skilled analyst to lead method development and GLP-compliant data handling. You will calibrate equipment, plan projects, and guide analysts through daily analytical tasks, ensuring accurate results and timely reporting.

Responsibilities include setting up LCMS/MS, interpreting data, and coordinating maintenance with engineering. You will contribute to method SOPs and QA/QC processes while fostering a compliant laboratory

Qualifications

• GLP, safety and quality systems knowledge desirable.
• Experience with HPLC/LCMSMS instrumentation preferred.
• Ability to coordinate calibration and maintenance activities.

Responsibilities

• Identify calibration curve range for specific analyte based on literature and method development trials.
• Assign tasks to analysts, interpret results, discuss with Sr. Group Leader for further trials.
• Prepare investigation reports for failures/unexpected results.
• Plan projects to maximize instrument time and study throughput.
• Set up equipment (Mass Spectrometers) for daily analysis and maintain operations.
• Interpret results, investigate deviations, and report progress to SGL.

Job description

Department Bioanalytical Research & Development

Reporting to Sr. Group Leader

• Primary Responsibility Description

Research & Development

• Identify Calibration Curve Range for specific analytic based on literature search, optimization of chromatographic condition, parameters on LCMS/MS equipment, extraction technique, designing for method development trials.
• Assign activities to individual analysts on day to day basis, interpretation of development results and further discuss with SGL for further Trials.
• Prepare investigation report for failures/unexpected results.
• Project Planning as per the schedule to utilize full machine time.
• Perform Analysis
• Set-up the required equipment (Mass Spectrometers) for daily analysis
• Interpretation of results, investigate any deviation and correct, update progress to SGL.
• Execution and maintenance of GLP, safety and quality systems.
• Identification of Incurred Sample Re-Analysis (ISR) and Repeat Sample (RS) and submit report to SGL.
• Documentation & Review
• Prepare method SOPs, study plan and validation protocol for each molecule and submit to internal QC for their review.
• Review the method book and other compiled raw data on daily basis
• Compile the calibration data of HPLC and LCMSMS and submit to internal QC.
• Prepare incident reports, Deviations, query response for QA/QC/Sponsors
• Review of all controlled forms/logs/Laboratory Record Book filled by analysts on daily basis
• To acknowledge the maintenance performed by engineer,
• Review the guidance and follow the practice for routine analysis.
• Equipment Calibration & Maintenance
• To perform calibration of HPLC, coordinate with in-house engineering team for calibration of LCMSMS.
• Perform preventive maintenance of the system on daily/weekly basis
• Coordinate with maintenance engineer team for all preventive maintenance and break-downs, ensure continuous performance of respective equipment.
• Maintain schedule of calibration and review the calibration data of other small instruments of sample preparation area.
• Communication, Reporting & MIS
• Compile analysis data, fill-up in requisite report template, and submit to respective BQM and Report Writers in a timely manner.
• Reply to relevant BQM, /QA queries in co-ordination with team members
• Timely update to SGL/BI for study/validation/method development.
• Prepare Monthly Equipment Utilization reports, Shift schedules and update SGL accordingly.
• Conduct functional team meeting on weekly basis and join DFMT organize by SGL/BI.
• Guide and explain to avoid the failure and root cause analysis in practical challenges.
• Conduct training of Analysts for assigned activities like sample preparation, Batch submission, online documentation, Equipment handling and troubleshooting etc.
• Guide analyst for method development and trouble-shooting during analysis.
• Continuously provide guidance to analyst for areas like safety, GLP, documentation etc.
• Conduct trainings on SOPs, Bio-analytical Study Plan, Method Validation Plan, clinical updates and Protocol for Analysts.
• Ensure Training Records/training of Group members for timely completion
• To groom analyst to take up higher responsibilities within organization
• Responsible for approval of attendance and leaves of analyst group.
• Ensure the safety and well-being of departmental employees and provide assistance to resolve employee grievances.s and probation confirmation of new joinee.
• Responsible to manage departmental work in absence of reporting manager.
• Any other task assigned by reporting authority.
• Customer Satisfaction
• Sponsor satisfaction in terms of services provided by survey internal stakeholder or external.