MANJUNATH V

Biopharmaceutical Operations Professional with 14 years of experience in the Biopharmaceutical Industry. Excellent knowledge of and experience with processes involved in manufacturing, quality assurance,

commissioning and Qualifications. Strong history of contributing to company growth and product launches by implementing continuous process improvement and process optimizations. Ability to lead and motivate high performance teams while maintaining strict quality and regulatory standards. Proven experience in technical writing skills, authoring and reviewing of process investigations technical reports, standard operating procedures (SOP) and protocols. Proficient knowledge in Track wise, SAP, Evlms and DMS Vast knowledge in GMP and experience in regulatory agencies inspections and audits.

• Successfully completed the Commissioning and Qualification of new Single use multi-product facility to produce Mabs.
• Involved in the technology transfer of three Biosimilars from R&D scale to Production scale.
• Reduced the consumables and Raw materials cost around 10% at production scale.
• Successfully Optimized the Depth filtration system, Chromatography system, Chromatography columns, viral filtration system, TFF System and Freeze thaw system for three different Biosimilars at production scale.
• Implementation of 6S in production facility.
• Successfully faced and cleared EMA, USFDA and Health Canada audit.
• Successfully implemented new software for Centrifuge and Chromatography system.
• Successfully optimized the Microfiltration, Chromatography process at production scale level.
• Introduction of Ion Exchange Chromatogarphy technique for the purification of Recombinant Proteins.
• Successfully optimized the sterile filtration of Final product and increase the final yield from 20% to 30%.
• Successfully completed the commissioning and Qualification of Microbial Insulin manufacturing facility.
• Successfully implemented Automated Operations in the facility with Rockwell automation software.

• Batch planning as per production schedule.
• Leading the Team of 15 members for downstream operation of Different Biosimilars.
• Handling and review of Deviations, Change control and CAPA through Trackwise software.
• Review of BMR and SOP through File net software.
• Costing, Batch planning, BOM creation, Batch SAP closure through SAP software.
• Assisted in trouble shooting of production issues and participated in root cause analysis to prevent reoccurrence.
• Involved in the Commissioning and qualification of new facility through Valgenesis software.
• Involved in hands-on execution of the plant operations. Proper maintainer of the plant according to the cGMP procedures and Standard Operating procedures. Trained team members in equipment troubleshooting.
• Involved in the closure of Deviation, Change control and CAPA.
• Involved in the Qualification and Requalification of the process equipments.
• Preparation of BMR and SOP’s.
• Review of executed Batch Manufacturing Records.
• Involved in the Preparation of Process validation protocols, BMR and SOP’s.
• Involved in the Preparation of DQ, IQ and OQ documents.
• Involved in carrying out the purification process of Recombinant Human Insulin at production scale by using GEA cell separator, Pall chromatography system, Novasep chromatography system and TEL star freeze drying system.
• Packing and Unpacking of LPLC and RPHPLC Columns.