Team Lead / Rsearch scientist -BAL

Role & responsibilities

1. Managing the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines.

2. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated.

3. Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities.

4. Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements.

5. Ensure compliance to GLP and safety in Lab, Assessment and training of staff on GLP and SOPs and applicable regulatory guidelines.

1. Implementation of Standard Operating Procedure for the analytical method developed and general procedures. Ensure that all relevant SOPs are available in work place.
2. Ensure routine maintenance and calibrations of all the equipments used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc.
3. Ensure computerized systems used in the studies has been validated as per the regulatory requirement.
4. Review and provide inputs for the documents like protocol, study reports, method validation reports, method SOP’s etc. and finalize the same in co-ordination with other departments.
5. Review of the electronic generated data, raw data and logbooks to ensure validity and accuracy.
6. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure.

12. Approve the individual sample repeats, ISR and investigation of batch failures.

Preferred candidate profile

candidate with relavent 2-5 year of experience is most.