SANTHAKUMAR YOGANATHAN

Deputy Manager – Downstream Manufacturing

BioGenomics Ltd.

11.2012 - 05.2024

Planning, Execution and supervising the manufacturing operations as per the customer requirement, involving technical discussions with R&D and other service departments
Displayed proficiency in team leading, Batch planning and Material management
Worked on Development batches, Consistency campaign, Preclinical batches, Scale up batches and Process validation batches
Provide technical support and guidance for manufacturing operations
Monitoring operation steps and troubleshooting of operations/Equipment’s related to downstream process
Trouble-shoot and resolve technical equipment problems, process related downstream deviations and take corrective actions
Process planning, execution of downstream activities as per the schedule, direct the work to downstream associates & timely completion of operation related documents to archive the process objectives
Responsible for validation (IQ, OQ and PQ) of downstream equipment’s used for the operations
Monitoring, control and documentation of operations as per the SOPs
Evaluation and implementation of new technology or modified processes to downstream manufacturing by precipitation with technology transfer teams
Preparation of process flow diagram and assessment of equipment need for operations
Mining and evaluation of in-process data from the operation and QC, data trending
Reviewing, writing SOPs, qualification documents, cleaning documents, batch records, validation protocols and reports
Diagnosing and trouble-shooting of operational issues, investigations of process failures and find out the root cause
Good skill in SAP Business One, Production order posting and approval
Training the production and technical teams on proper usage of equipment and working in cGMP facility