JOB PROFILE• Handle team for effective management of manufacturing activities.• Handled technology transfer from Process Development to Manufacturing.• Analyze and prepare the new project fitments for current existing systems.• Having experience in evaluation of the new equipment’s required for manufacturing activity.• Having experience in handling of Axichrome Columns (600/300).• Trouble shooting of the equipment errors during batch activity.• Scale up for… Show more JOB PROFILE• Handle team for effective management of manufacturing activities.• Handled technology transfer from Process Development to Manufacturing.• Analyze and prepare the new project fitments for current existing systems.• Having experience in evaluation of the new equipment’s required for manufacturing activity.• Having experience in handling of Axichrome Columns (600/300).• Trouble shooting of the equipment errors during batch activity.• Scale up for manufacturing of bio-therapeutic proteins like Recombinant Monoclonal Antibody(Rituximab, Omalizumab, GCSF, PEG GCSF).• Support process validation studies and activities. Data compilation for report preparations.• Participation in all validation and cGMP manufacturing batches.• Issuance and submission of all quality related and process documents including change control,• SAP Activities related to Process Order, Raw material managements, Maintenance of notifications andDrug Substance transaction.• Supervising and training of newcomer or trainees.Achievements:1. Implemented automated process recipes in manufacturing to avoid manual interventions and batchloss due to errors.2. Simplified the process stage in DS stage to reduce the manual interventions.3. Implemented advanced equipment’s in place of existing equipment’s by performing step validation.4. As part of COGS reduction, implemented alternative vendors and reduced the total batch coast.5. Increased batch capacity from 2.5 batches to 5 batches per month by implementing additionalequipment.6. Proposed to increase the batch capacity from 5 batches to 7 batches per month and projectexpansion is under progress. Show less

JOB PROFILE• Downstream Processing of MAB’s for 2 kL scale.• Handle team for effective management of manufacturing activities.• Handled technology transfer from Process Development to Manufacturing.• Analyze and prepare the new project fitments for current existing systems.• Having experience in evaluation of the new equipment’s required for manufacturing activity.• Having experience in handling of Axichrome Columns (600/300).• Trouble shooting of the equipment… Show more JOB PROFILE• Downstream Processing of MAB’s for 2 kL scale.• Handle team for effective management of manufacturing activities.• Handled technology transfer from Process Development to Manufacturing.• Analyze and prepare the new project fitments for current existing systems.• Having experience in evaluation of the new equipment’s required for manufacturing activity.• Having experience in handling of Axichrome Columns (600/300).• Trouble shooting of the equipment errors during batch activity.• Scale up for manufacturing of bio-therapeutic proteins like Recombinant Monoclonal Antibody(Rituximab, Omalizumab, GCSF, PEG GCSF).• Support process validation studies and activities. Data compilation for report preparations.• Participation in all validation and cGMP manufacturing batches.• Issuance and submission of all quality related and process documents including change control,• SAP Activities related to Process Order, Raw material managements, Maintenance of notifications andDrug Substance transaction.• Supervising and training of newcomer or trainees.Achievements:1. Established Clean Equipment Hold Time for Process vessels.2. Established intermediate cleaning procedure for buffer vessels.3. Established sterile and dirt hold time for process vessels.4. Implemented new in-housing Derouging process for all SS vessels.5. Established long term storage time period for chromatography columns.6. Established hold time for buffers before filtration Show less

Working in cell culture manufacturing with 1KL capacity.responcible for daily production activity in downstream process.Completion of Batch with out delay in process.online documentation and timely review and submission of the document for batch closure.

working in microbial vaccine manufacturingresponcible for downstream manufacturing

working in molecular biology and down stream process of protein purification (GCSF).Optimization of purification technology for GCSF protein.