Research Associate III

Job Responsibilities:

1. Process development, scale-up, scale-down and transfer

 Undertake referencing and review of literature and provide inputs to the undergoing projects and lab experiments.

 Planning, execution and analysis of any lab experiments.

 Prepare experimental set-up and conduct experiment for the screening of clones at flask level/ fermenter level.

 Upstream process development and optimization at different scales of fermenters.

 Scale-up of the final upstream process to pilot fermenter under the guidance of scientists.

 Scale down model of upstream manufacturing process and process characterization studies under the guidance of scientists.

 Support to Technology Transfer Batches at Manufacturing site.

 Preparation and review of Batch Process Record, SOP and other lab documents as per the requirements.

2. Microbial Limit Testing

 Assist in method development for microbial enumeration of API

 Conduct routine sample analysis of API as per Standard Analytical Procedures.

3. Materials and equipment management

 Maintain inventory of chemicals/ consumables

 Maintenance of lab equipment (AMC/Validation/Calibration) and IQ/OQ/PQ of new instruments as per SOP.

4. Regulatory and compliance

 Adhere to USV Quality policy.

 Adherence to regulatory, SOP and safety guidelines for all processes.

 Preparation of any lab audit.

5. Learning and improvement

 Attend all mandatory training.

 Take initiatives for self-development on recent technical updates in your own area of work.

 Provide training to new joinee as per Role Curriculum.

The responsibilities for this role are not limited to the responsibilities listed above.