Group Leader, Bioanalytical Research

Key Responsibilities

• Research & Development
• Identify Calibration Curve Range based on literature search, optimize chromatographic conditions, parameters on LCMS/MS equipment, extraction techniques, and design method development trials.
• Assign daily activities to individual analysts, interpret development results, and discuss with Sr. Group Leader (SGL) for further trials.
• Prepare investigation reports for failures or unexpected results.
• Plan projects according to the schedule to maximize machine utilization.
• Perform Analysis
• Set up required equipment (Mass Spectrometers) for daily analysis.
• Interpret results, investigate and correct any deviations, and update progress to SGL.
• Execute and maintain GLP, safety, and quality systems.
• Identify Incurred Sample Re-Analysis (ISR) and Repeat Sample (RS) and submit reports to SGL.
• Documentation & Review
• Prepare method SOPs, study plans, and validation protocols for each molecule and submit for internal QC review.
• Review method books and other compiled raw data daily.
• Compile calibration data of HPLC and LCMSMS and submit to internal QC.
• Prepare incident reports, deviations, and query responses for QA/QC/Sponsors.
• Review all controlled forms, logs, and Laboratory Record Books filled by analysts daily.
• Acknowledge maintenance performed by engineers.
• Review guidance and follow practices for routine analysis.
• Equipment Calibration & Maintenance
• Perform calibration of HPLC.
• Coordinate with the in-house engineering team for LCMSMS calibration.
• Perform preventive maintenance of the system on a daily/weekly basis.
• Coordinate with the maintenance engineer team for all preventive maintenance and breakdowns, ensuring continuous equipment performance.
• Maintain the calibration schedule and review calibration data for other small instruments in the sample preparation area.
• Communication, Reporting & MIS
• Compile analysis data, fill in requisite report templates, and submit to respective BQM and Report Writers.
• Respond to relevant BQM and QA queries in coordination with team members.
• Provide timely updates to SGL/BI for study/validation/method development.
• Prepare monthly equipment utilization reports and shift schedules, updating SGL.
• Conduct functional team meetings weekly and join DFMT organized by SGL/BI.
• Guide and explain to avoid failures and conduct root cause analysis for practical challenges.
• Team Handling/Team Development
• Train analysts on assigned activities such as sample preparation, batch submission, online documentation, equipment handling, and troubleshooting.
• Guide analysts on method development and troubleshooting during analysis.
• Continuously provide guidance to analysts on safety, GLP, documentation, etc.
• Conduct training on SOPs, Bio-analytical Study Plan, Method Validation Plan, clinical updates, and Protocols for analysts.
• Ensure timely completion of training records and training for group members.
• Groom analysts to take up higher responsibilities within the organization.
• Approve attendance and leaves for the analyst group.
• Ensure the safety and well-being of departmental employees and assist in resolving employee grievances.
• Manage departmental work in the absence of the reporting manager.
• Perform any other tasks assigned by the reporting authority.
• Customer Satisfaction
• Ensure sponsor satisfaction in terms of services provided through internal stakeholder or external surveys.

Requirements & Tech Stack

• LCMS/MS equipment
• HPLC
• Mass Spectrometers
• GLP
• SOPs
• QA/QC
• BQM
• BI
• DFMT

Qualifications

• Reporting to Sr. Group Leader
• Location: Ahmedabad