Analyst Group Leader: Bioanalytical Research

Role & responsibilities

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.

Team handling/team development

• 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.
• Responsible for approval of individual employees performance goals and probation confirmation of new joinee.
• Responsible to manage departmental work in absence of reporting manager.
• Any other task assigned by reporting authority.