DOWN STREAM PRODUCTIONExperienced professional proficient in manufacturing Ranibizumab, Teriparatide, Filgrastim , Pegylated Filgrastim and Romiplostim drug substances. Skilled in operating chromatography and TFF systems such as Cytiva, Sartorius TFF (both automated and manual), IDMC Vessel automations.Expertise extends to various column operations including AEX, GFC, CEX, HIC, and MMC, encompassing column packing/unpacking (BPG and Quick scale), evaluation, Stax Depth… Show more DOWN STREAM PRODUCTIONExperienced professional proficient in manufacturing Ranibizumab, Teriparatide, Filgrastim , Pegylated Filgrastim and Romiplostim drug substances. Skilled in operating chromatography and TFF systems such as Cytiva, Sartorius TFF (both automated and manual), IDMC Vessel automations.Expertise extends to various column operations including AEX, GFC, CEX, HIC, and MMC, encompassing column packing/unpacking (BPG and Quick scale), evaluation, Stax Depth filter utilization. Strong aptitude in planning shift activities, ensuring smooth production processes. Show less

This job involves the following tasks:- Verifying and preparing equipment and instruments for the production process.- Organizing process accessories and consumables before batch execution.- Issuing raw material requirements for production.- Creating process-related standard operating procedures (SOPs) and ensuring readiness of downstream areas.- Operating downstream equipment according to SOPs, such as TFF system buffer, refolding vessels, AKTA pilot… Show more This job involves the following tasks:- Verifying and preparing equipment and instruments for the production process.- Organizing process accessories and consumables before batch execution.- Issuing raw material requirements for production.- Creating process-related standard operating procedures (SOPs) and ensuring readiness of downstream areas.- Operating downstream equipment according to SOPs, such as TFF system buffer, refolding vessels, AKTA pilot system, pH and conductivity meters, and autoclaves.- Calibrating and verifying equipment and instruments.- Autoclaving process materials and required accessories.- Executing production batches in the downstream process area and submitting reports.- Preparing and executing protocols.- Coordinating with the engineering department for equipment maintenance and calibration.- Testing in-process samples for measurements like OD, pH, and conductivity.- Reporting deviations to supervisors or Quality Assurance (QA).- Ensuring workplace safety and attending training sessions.- Updating facilities and related documentation and monitoring daily activities.- Additional responsibilities may include informing the engineering team of breakdowns, coordinating with various departments, and performing other assigned . Show less