Mangesh Yadav

Biotechnologist with 2+ years of experience in upstream fermentation and industrial bioprocessing. Expert in managing 100L to 100KL scales, DCS/MES automation, and ensuring strict GMP compliance. Specialized in end-to-end batch management, Process Qualification (PQ), and executing Validation and Development batches for commercial scale-up.

Executive - Biocon Biosphere - Visakhapatnam, India

(2024-02)

• System Validation & OQ: Actively involved in Operational Qualification (OQ) for MES (Manufacturing Execution Systems) and PCS (Process Control Systems) to verify that system functions meet design specifications.
• Dry & Mock Runs: Executed Dry Runs to test automation sequences without materials and Mock Runs to simulate actual batch conditions to validate sterilization (SIP/CIP) and feeding logic.
• Process Validation & Qualification: Successfully executed Process Qualification (PQ) protocols and Validation Batches to ensure consistency and compliance with regulatory standards.
• Development & Scale-up: Managed Development Batches to optimize yield and stability during the transition from pilot to 100KL commercial scale.
• End-to-End Batch Management: Expert in the full lifecycle of Batch Handling, including seed transfer, inoculation, growth monitoring, and final batch harvesting.
• Vessel Operations & Media Prep: Executed media preparation in the MPV (Media Preparation Vessel), managed CIP vessels for cleaning, and operated the NDV (Nutrient Dosing Vessel) for precise dosing.
• Facility & Environmental Monitoring: Tracked facility conditions across cold rooms, CRT (Controlled Room Temperature) rooms, and ambient rooms using the Environmental Monitoring System (EMS), and monitored 20KL liquid oxygen tanks.
• Cross-Functional Coordination: Collaborated actively with Warehouse, QA, QC, QCM, Downstream processing, and Engineering (Mechanical, Electrical, Instrumentation, and Utility) departments to maintain seamless operational flow.
• Technical Integrity: Pressure Tests, and Leakage Tests for vessels; executed SIP/CIP cycles for fermenters and nutrient vessels.
• Calibration & Analysis: Responsible for pH probe calibration and monitoring growth kinetics via WCW (Wet Cell Weight) to dynamically adjust feeding strategies.
• Automation, Compliance & Housekeeping: Managed daily operations via DCS/MES; maintained rigorous BMR (Batch Manufacturing Records) and GMP documentation, and oversaw routine housekeeping activities for audit readiness.

Intern - IPCA Laboratories - Mumbai, Maharashtra

(2023-02 - 2023-03)

• Supported media preparation, media sterilization, and autoclaving processes.
• Gained hands-on experience in inoculation techniques and peristaltic pump handling.
• Assisted in optimizing feeding strategies for increased product yield and content.
• Performed Gram staining, pH & DO calibration/monitoring, and Wet Cell Weight (WCW) analysis.
• Monitoring of Temperature, pH, Do2, Air flow and Agitation.

M.Sc. - Industrial Biotechnology - Dr. Homi Bhabha State University (2021 - 2023)

B.Sc. - Biotechnology - Elphinstone College (2018 - 2021)

Intermediate - Dr. Bhim Rao Ambedkar Inter College (2016 - 2016)

High School - St. Xavier's Inter College (2013 - 2013)