Research Associate, Upstream Process Development

Description :

To execute the bench level cell culture experiments, data recording and representation in appropriate format; to maintain inventory, equipment and lab space within the upstream process development function in product development domain of Biologics with the objective of executing experiments supporting development of upstream process and providing execution support to operations.

Execution of experiments

Preparation of media, feed and additive stock solutions.

* Revival of cell banks and maintenance of seed trains to initiate production runs.

* Cleaning and sterilization of AMBR clamp plates. Cleaning and setup of AMBR as per SOP.

* Performing regular basic operations of cleaning of bioreactors, pH and DO probe calibration, assembly and sterilization of bioreactors following SOP.

* Writing experiment specific program for ambr operation and assigning control set points for bioreactors as per process design.

* Media fill and inoculation of shake flask, AMBR, glass, wave and single-use bioreactors.

* Day-to-day operation of cell culture processes related to sampling, feeding and in-process analysis using BGA, Vi-cell, Cedex and Osmometer.

* Monitoring of process parameters and informing team leads in case of any deviation.

* Execution of corrective action/s as per suggestion provided by TLs.

* Labelling and archival of cell free samples as per procedure.

* Supporting TLs in troubleshooting and deviation management.

* Verification of AMBR program and Bioreactor set points to ensure the correctness.

DOCUMENTATION: Creating raw data repository, Drafting execution documents

* Record expermental data (online and offline) into data management system (LNBs/ ELN/ DRSs) following ALCOA.

* Transcribe raw data from LNB/ ELN/ DRS to the templated electronic format.

* Recording of equipment usage and details of maintenance into respective log books.

* Drafting and revision of SDPs and DRSs for media, feed, other solutions and for process unit operations.

* Providing support in report writing - graph preparation and compiling data in tabular format.

LAB MANAGEMENT, SAFETY & Quality: Inventory, Equipment and Lab maintenance

* Cleaning, replacing reagents, calibration and making instruments ready for use in the begining of the day as per the need following SOPs.

* Ensuring completion of preventive maintenance of equipment as per the schedule.

* Inventory management for equipment and process (raw materials and consumables) and coordinatinating with indenting team to eliminate downtime.

* Following-up with Lab-Ops functions for timely delivery and movement of material to/ from warehouse.

* Upkeeping laboratory by maintaining ordeliness and following standard safety and quality practices.

* Playing designated safety role.

* Performing procedural actvities related to procurement, commissioning, assest capitalization and decomissioning of equipments.

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