Ganesh Tsavatapalli

Experienced professional with expertise in various aspects of biopharmaceutical processes, including preparation of validation protocols, reports, and consistency reports for different products. Skilled in handling single-use bioreactors at different scales and proficient in planning production schedules based on product requirements using Gantt charts. Conducts thorough risk assessments using FMEA mode and actively participates in CAPA actions, evaluating, implementing, and tracking for closure. Demonstrates proficiency in preparation of manufacturing-related documents such as SOPs, BMRs, and checklists. Expertise in technology transfer, scale-up, manufacturing, and process support of upstream processes. Collaborates with QA, QC, R&D, and engineering teams to resolve daily operational issues. Leads continuous improvement initiatives to optimize unit operations and improve yield. Exceptional multitasking abilities to prioritize activities for quick execution of critical path tasks. Skilled at building consensus among cross-functional teams. Proven track record in troubleshooting process and plant operations. Provides continuous training and support to the team in operations and manufacturing activities. Implements 5S principles in operations and contributes to recipe development for manufacturing processes. Handles major and critical deviations with cross-functional teams and conducts DI assessments for deviations. Involved in Lean and Six Sigma projects. Compliance professional with demonstrated expertise in regulatory adherence and risk management. Known for developing and implementing compliance programs that align with industry standards. Strong focus on team collaboration and achieving results while maintaining a flexible approach to evolving needs. Skilled in policy development, auditing, and problem-solving to ensure organizational integrity and trust. Compliance professional with demonstrated expertise in regulatory adherence and risk management. Adept at developing and implementing compliance programs that ensure alignment with industry standards. Known for strong focus on team collaboration and achieving results, with flexible approach to evolving needs. Skilled in policy development, auditing, and problem-solving, ensuring organizational integrity and trust.

• Bio-contribution award winner or the year 2008-2009 in BIOCON for the optimizing the process in the perfusion which lead to the company in the direct saving of 2 million $.
• Achieved Gold Medal in National level paper presentation competition.
• Achieved best Contribution award from NOVARTIS.