Bioanalytical Research Scientist

VerGo Pharma Research; Panaji; On-site; INR 600,000 - 1,200,000; Full time

Job summary

VerGo Pharma Research in Panaji, India seeks an experienced Analyst to ensure data integrity and compliance with GLP, GCP, and documentation practices. You will manage LC-MS/MS instrumentation, calibration, maintenance, and troubleshooting, coordinating with QA and service vendors to meet project timelines.

The role includes method development/validation, study sample analysis, literature review, and trainer responsibilities for LC-MS/MS operators.

Qualifications

• Ensures data integrity and compliance with good documentation practices, GLP, and GCP.
• LC-MS/MS handling, calibration, maintenance and troubleshooting of instruments.
• Contact service engineers/vendors in co-ordination with Team leader.
• In absence of Team Leader coordinate with QA for smooth conduction of projects to meet timelines.
• Preparation of SOP, STP, Protocol and study plan as per requirement.
• Ensure the material availability before initiation of project.
• Plan method development, method validation and study sample analysis in coordination with Project In-charge/Team Leader.
• Project sample analysis for estimation of drugs in biological fluid using LC-MS/MS as per STP/Protocol.
• Perform method development and validation.
• Collect and review literature to perform method development.
• Perform tuning of molecules prior to method development when required.
• Conduct chromatographic operation and analyse study samples on the instrument.
• Review results of method development/validation and sample data for acceptance per SOP.
• Create pdf of result tables and excel sheets of development/validation data.
• Review LC-MS/MS audit trail data.
• Train operators to perform activities accurately.
• Provide effective training for LC-MS/MS operations to operators.

Responsibilities

• Overall responsible as an Analyst.
• Responsible for ensuring data integrity and compliance with good documentation practices, good laboratory practices and good clinical practices.
• Responsible for LC-MS/MS handling, calibration, maintenance and troubleshooting of instruments and equipments.
• Contact service engineers/vendors in co-ordination with Team leader.
• In absence of Team Leader co-ordinate with QA department for smooth conduction of projects to meet the timelines.
• Preparation of SOP, STP, Protocol and study plan as per requirement.
• Ensure the material availability before initiation of project.
• To plan method development, method validation and study sample analysis activity in co-ordination with Project In- charge /Team Leader.
• 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.
• Perform Method development and validation.
• Collect and review literature to perform method development.
• To perform tuning of molecules prior to method development and when required.
• To conduct chromatographic operation and analyse the study samples on the instrument.
• To review the results of method development, method validation experiment and subject sample analysis data for its acceptance as per in-house SOP.
• To create pdf of result tables and excels of method development, method validation experiment and subject sample analysis data etc.
• To review LC-MS/MS audit trail data.
• Train operators to perform their activities accurately.
• To provide effective training for LC-MS/MS operations to operators.

Education

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

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.