Group Leader - Analyst

We are looking for a Group Leader – Analyst to lead and supervise bioanalytical research activities, including method development, analytical operations, documentation, equipment management, quality compliance, and analyst development.

The role involves managing day-to-day activities of analysts, ensuring timely execution of studies, troubleshooting analytical challenges, maintaining GLP and safety standards, and coordinating with internal quality, engineering, reporting, and management teams.

Key Responsibilities

1. Research & Development

• Identify calibration curve ranges for specific analytes through literature research.

• Optimize chromatographic conditions and analytical parameters on LC-MS/MS equipment.

• Develop and optimize sample extraction techniques.

• Design and execute method development trials.

• Assign day-to-day activities to individual analysts.

• Interpret method development results and discuss further trials with the Senior Group Leader.

• Prepare investigation reports for analytical failures and unexpected results.

• Plan project activities according to study schedules to maximize equipment and machine utilization.

2. Analytical Operations

• Set up and operate required analytical equipment, including mass spectrometers, for daily analysis.

• Review and interpret analytical results.

• Investigate deviations and implement appropriate corrective actions.

• Provide regular progress updates to the Senior Group Leader.

• Ensure execution and maintenance of GLP, safety, and quality systems .

• Identify Incurred Sample Re-Analysis (ISR) and Repeat Sample (RS) requirements and submit relevant reports.

3. Documentation & Review

• Prepare method SOPs, study plans, and validation protocols for individual molecules.

• Submit documentation to internal Quality Control for review.

• Review method books and compiled raw data on a daily basis.

• Compile HPLC and LC-MS/MS calibration data and submit it to internal Quality Control.

• Prepare incident reports, deviation reports, and responses to queries from QA, QC, and sponsors.

• Review controlled forms, logs, and Laboratory Record Books completed by analysts.

• Review equipment maintenance records and acknowledge maintenance activities performed by engineers.

• Ensure compliance with applicable guidance and established practices for routine analysis.

4. Equipment Calibration & Maintenance

• Perform calibration of HPLC equipment.

• Coordinate with the engineering team for LC-MS/MS calibration.

• Perform preventive maintenance of analytical systems on a daily/weekly basis.

• Coordinate with maintenance engineers for preventive maintenance and equipment breakdowns.

• Ensure continuous and reliable performance of assigned equipment.

• Maintain equipment calibration schedules.

• Review calibration data for small instruments used in the sample preparation area.

5. Communication, Reporting & MIS

• Compile analytical data and complete the required reporting templates.

• Submit reports to relevant BQM and Report Writing teams within defined timelines.

• Respond to BQM and QA queries in coordination with team members.

• Provide timely updates to the Senior Group Leader and relevant stakeholders regarding study, validation, and method development activities.

• Prepare monthly equipment utilization reports.

• Prepare shift schedules and communicate updates to the Senior Group Leader.

• Conduct weekly functional team meetings.

• Participate in cross-functional meetings organized by the Senior Group Leader/Business Intelligence team.

6. Team Handling & Development

• Guide analysts in identifying and preventing analytical failures through practical troubleshooting and root-cause analysis.

• Train analysts on sample preparation, batch submission, online documentation, equipment handling, and troubleshooting.

• Guide analysts during method development and analytical troubleshooting.

• Provide continuous guidance on safety, GLP, documentation, and laboratory practices.

• Conduct training on SOPs, Bioanalytical Study Plans, Method Validation Plans, clinical updates, and protocols.

• Ensure timely completion and maintenance of training records.

• Develop and groom analysts for higher responsibilities.

• Review and approve attendance and leave requests for the assigned analyst group.

• Ensure the safety and well-being of departmental employees.

• Assist in resolving employee grievances.

• Support probation confirmation processes for new joiners.

• Manage departmental activities in the absence of the reporting manager.

• Perform other responsibilities assigned by the reporting authority.

7. Customer / Sponsor Satisfaction

• Ensure quality and timely delivery of analytical services.

• Support sponsor satisfaction through effective communication, timely responses, and adherence to agreed study requirements.

• Coordinate with internal and external stakeholders to address relevant queries and service requirements.

Key Skills & Competencies

• Strong knowledge of LC-MS/MS and HPLC .

• Hands-on experience in bioanalytical method development.

• Knowledge of chromatographic method optimization.

• Understanding of sample extraction techniques.

• Knowledge of method validation and analytical documentation.

• Strong understanding of GLP, quality, safety, and laboratory practices .

• Analytical troubleshooting and root-cause analysis skills.

• Strong documentation and report-writing abilities.

• Team handling and people management skills.

• Training and mentoring capabilities.

• Good communication and coordination skills.

• Ability to manage multiple studies and meet defined timelines.

• Strong attention to detail and data accuracy.

Preferred Technical Exposure

• LC-MS/MS

• HPLC

• Bioanalytical Method Development

• Method Validation

• Sample Preparation & Extraction

• Calibration & Equipment Maintenance

• GLP Compliance

• Quality Documentation

• Investigation & Deviation Handling

• Root Cause Analysis

• Analytical Data Review

• Laboratory Documentation

Job Requirements: LC-MS/MS, HPLC, Bioanalytical Method Development, Method Validation, Sample Preparation, Sample Extraction, Calibration, Equipment Maintenance, GLP Compliance, Quality Documentation, Investigation Handling, Deviation Handling, Root Cause Analysis, Analytical Troubleshooting, Analytical Data Review, Laboratory Documentation, Report Writing, Team Handling, People Management, Training, Mentoring, Communication, Coordination, Attention to Detail, Data Accuracy