Bioanalytical Research Associate

VerGo Pharma Research; Panaji, South Goa District; On-site; INR 600,000 - 900,000; Full time

Job summary

VerGo Pharma Research seeks an experienced Analyst to ensure data integrity and GLP/GCP compliance in LC-MS/MS workflows. You will manage instrument calibration, maintenance, and troubleshooting while coordinating with QA and vendors under the Team Leader's guidance.

You will also prepare SOPs, study plans, and protocols, ensuring material readiness and timely project execution. Training operators and contributing to method development are key aspects of the role.

Qualifications

• Experience with data integrity and GxP practices.
• Experience in LC-MS/MS handling and instrument troubleshooting.
• Ability to coordinate with QA and service engineers.
• Ability to prepare SOPs, STPs, protocols and study plans.
• Ensure material availability before project initiation.
• Plan method development, validation and study sample analysis.

Responsibilities

• Ensure data integrity and compliance with good documentation, GLP and GCP.
• Handle LC-MS/MS, calibration, maintenance and troubleshooting of instruments.
• Coordinate with service engineers/vendors in collaboration with Team Leader.
• In absence of Team Leader, coordinate with QA to ensure project timelines.
• Prepare SOP, STP, Protocol and study plan as required.
• Ensure material availability before project initiation.
• Plan method development, validation and sample analysis in coordination with Project In-Charge/Team Leader.
• Perform method development and validation for LC-MS/MS analyses.
• Review literature to support method development.
• Tune molecules prior to method development when needed.
• Conduct chromatographic operations and analyze study samples on instruments.
• Review results for acceptance per in-house SOP.
• Create PDFs of result tables and data sheets.
• Review LC-MS/MS audit trail data.
• Train operators to perform LC-MS/MS operations.

Skills

Data integrity

Documentation practices

Team coordination

Training others

Education

MSc in Chemistry/Industrial Chemistry/Pharma-related

Tools

LC-MS/MS

Instrument maintenance

Audit trails

Job description

Role & responsibilities

Overall responsible as an Analyst:-

1. Responsible for ensuring data integrity and compliance with good documentation practices, good laboratory practices and good clinical practices.

2. Responsible for LC-MS/MS handling, calibration, maintenance and troubleshooting of instruments and equipments.

3. Contact service engineers/vendors in co-ordination with Team leader.

4. In absence of Team Leader co-ordinate with QA department for smooth conduction of projects to meet the timelines.

5. Preparation of SOP, STP, Protocol and study plan as per requirement.

6. Ensure the material availability before initiation of project.

7. To plan method development, method validation and study sample analysis activity in co-ordination with Project In- charge /Team Leader.

8. Project sample Analysis for the estimation of drugs in the biological fluid by using LC-MS/MS as per method STP, Protocol and in-house SOPs under team leader guidance.

9. Perform Method development and validation.

10. Collect and review literature to perform method development.

11. To perform tuning of molecules prior to method development and when required.

12. To conduct chromatographic operation and analyse the study samples on the instrument.

13. To review the results of method development, method validation experiment and subject sample analysis data for its acceptance as per in-house SOP.

14. To create pdf of result tables and excels of method development, method validation experiment and subject sample analysis data etc.

15. To review LC-MS/MS audit trail data.

16. Train operators to perform their activities accurately.

19. To provide effective training for LC-MS/MS operations to operators.

Preferred candidate profile

MSc in Chemistry/ Industrial Chemistry/Pharma-Bachelor’s/Master’s degree or related field.

5–8 years of Analyst roll in BA/BE Centre.