Sushma Jogi

Experience

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  Stempeutics Research Pvt. Ltd.

  Jun 2018 - Jul 2021

  Executive

  Isolation and purification of human bone marrow derived MNCs from bone marrow aspirate, expansion of MNCs as per GMP standards. Manufacturing of stem cell based products(DP); Upstream & Downstream technologies; Cell banking (MCB & WCB), thawing, revival, expansion, harvest and fill and finish (packaging) and cryopreservation for clinical studies.Cell physiology, sub culturing and maintenance of cell culture for process improvement and process optimization studies.SOP,MFR, BPR(BMR), study summary reports preparation and review as per regulatory requirements, GMP, Schedule M guidelines.Maintenance and monitoring of manufacturing equipment's; Preparation of IQ, OQ, PQ documents and execution of activities and summary report preparation for Cryoshipper. Equipment/Instrument requalification, summary report review.Clinical trial; Randomized CT, IMP management activities, cold chain management, supply of IMP to CT site, coordination with clinical research team, destruction of unused/returned product, document preparation review and compilation asper regulatory requirement, ICH-GCP guidelines.Manufacturing of cosmetic active ingredient; downstream using TFF, manufacturing of cosmetic products for clinical trials SOP, BPR documentation asper guidelines.Change control, Deviation report, Incident report filing and addressing the documents. Internal Audits, GMP monitoring.QA support: Document controller; Distribution, withdrawal, archival, retrieval of controlled documents. Preparation, tracking and updating of master index. Show less

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  Stempeutics

  Apr 2021 - Mar 2022

  Senior Executive
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  Immuneel Therapeutics Pvt. Ltd.

  Mar 2022 - Apr 2024

  Manufacturing Scientist