Sr. Research Scientist / Group Leader-Bio-analytical

Role & responsibilities

1. Plan, execute, and complete the method development and method validation, execute methods for the analysis of study samples within the committed timelines.

2. Supervision of sample processing and analysis for BA/BE studies as per applicable regulatory requirements.

3. Preparation and review of bioanalytical method validation reports, method SOPs and study reports.

1. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc.
2. Review of protocols, electronic generated data, raw data forms and logbooks, to ensure validity and accuracy.

6. Ensure timely archival of documents in both hard copy and soft copy formats.

7. Identification and compilation of the individual sample repeat, ISR and investigation of batch failure. To generate the result summaries and chromatograms.

8. For instrument troubleshoot and coordinate with the instrument engineers regarding the break down.

9. Assign and supervise projects for the research scientist and research associate and supervise all the activities in the assigned group and to train a newly joined team member.

10. Ensure compliance to GLP and safety in the bioanalytical laboratory.

11. To operate the instrument and to maintain the required consumables for equipment’s like LC-MS/MS.

12. Assist HOD during preparation audit responses for various regulatory bodies.

1. Provide training for departmental personnel on SOP, current scientific and regulatory requirements.
2. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure.

Preferred candidate profile

B Pharma / M Pharma OR M.sc in chemsitry or biochemistry with 2-7 years of expereince in bio-analytical deaprtment in any apporved CRO.

Perks and benefits

5 Lacs to 12 Lacs