Siddharth Thumma

Manufacturing Associate

Moderna

11.2023 - Current

Executed manufacturing operations in compliance with cGMP and FDA standards, achieving a 99% audit readiness score across all production activities
Performed aseptic operations in Grade A/B cleanroom environments, ensuring zero contamination incidents and maintaining 100% compliance with sterile processing protocols
Operated and maintained biomanufacturing equipment, including bioreactors, chromatography systems, and filtration units, with a 98% equipment uptime rate
Prepared and executed production batch records and Standard Operating Procedures (SOPs) with 100% accuracy, contributing to consistent product quality and regulatory compliance
Monitored and controlled critical production parameters, achieving >95% lot acceptance rates for drug substance and drug product manufacturing
Collaborated in the review and approval of manufacturing batch records, ensuring timely documentation closure within an average of 48 hours post-production
Conducted environmental monitoring and adhered to sterile gowning protocols, supporting contamination-free production and meeting FDA and EMA standards
Participated in root cause investigations and implemented Corrective and Preventive Actions (CAPAs), reducing recurring deviations by 15%
Led or supported inventory management tasks, ensuring 98% availability of raw materials and consumables for seamless manufacturing operations
Contributed to process optimization and continuous improvement projects, reducing production cycle times by 10% and increasing overall yield by 5%
Maintained and cleaned manufacturing equipment and cleanrooms per GMP guidelines, ensuring readiness for audits and inspections

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