Mythri Kodidela

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August Bioservices
Sr. Validation Engineer
Mythri Kodidela is Senior Validation Engineer, MSAT, at August Bioservices, a US-based CRO/CDMO, offering a full range of drug discovery, drug development, and drug manufacturing capabilities from preclinical to commercialization. She is skilled in US FDA and EMA regulations for commercial pharmaceutical products. Mythri has 9 years of pharmaceutical validation experience in process validation, cleaning validation, media fill qualification, cleanroom qualification, equipment and utility qualification, risk analysis, and project management. Mythri has overseen all aspects of project management for engineering and validation programs from project initiation to closure for multiple development (R&D), clinical, and commercial products. She is an experienced industry professional who has managed cross-functional teams leading to timely completion of project activities. Mythri holds an MBA from the University of Iowa and a master’s degree in pharmaceutical sciences from Campbell University.

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Figure 3: Example of spray coverage image and clean in place (CIP) execution image used as supporting evidence.
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Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches....