Ashutosh Kumar Email & Phone Number

Singapore

Singapore

Worked on Commissioning and Qualification for the various clients.➢ Worked on preparation of various documents like VMP, SLIA, CLIA, commissioning, IOQ, PQ through KNEAT Paperless Validation system.➢ Worked on execution of commissioning, IOQ, IQ, OQ and PQ protocol on KNEAT at the client site.➢ Coordinated the activities with vendor and SME on completing the IQ and OQ protocol preparation and execution.➢ Lead the resolution for the deviations encountered during protocol execution.➢ Worked with the vendors and operation teams for timely preparation and execution of protocols.➢ Attending the project meetings on status of the deliverables.

Singapore

Cell culture Upstream• Worked with the 25 members team for the Humira production• Performing all day to day activities starting from Vial thaw to inoculum scale up.• Bioreactor CIP, Population of Bioreactors, Pressure test, SIP, media fill, Sampling, Inoculation, and harvest.• Coordinating with Central services and Downstream for all day to day operations.• Coordinating with the Engineering and maintenance team for all maintenance and calibration activities• Coordinating with QA for SOP preparation and approval.• Participating in all upstream improvements and providing suggestions for improving the workflow.• Ensuring GMP compliance of facility and process; audit readiness and closure of audit observations.Participating in project review meetings with internal cross-functional teams.• Emergency response team member and Culture champion• Involved in USFDA, HSA and JAPAC audits.ACHIEVEMENTS• Provided the idea of addition of Load cells to the wave Bioreactors and involved in the Successful addition of Load cell cells to the Bioreactors and Qualification of the Wave bioreactors.• Provided the idea of disabling the alarms of source bioreactors while transfer to the designation bioreactor.• Worked on the Change Plan of FIT improvements starting from initiation to the approval of the change plan.• Driving culture to the entire site as a culture champion.• Won various prizes for highlighting safe work practices.

Bengaluru Area, India

Cell culture-Upstream Worked on Commissioning and Qualification of new lab having upto 2000 litres of Bioreactor. Worked on procurement of equipment's, raw materials and consumables required for production activity. Working on validation master plan, SLIA,CLIA.• Leading a Bioreactor team of 6 members for all day to day activities of production area.• Involved in SAT,FAT, IQ, OQ, PQ and area qualification of production area.• Worked on preparation of user requirement specification, IQ and OQ documents.• Worked various equipment's IOQ and OQ.• Worked on equipment, instruments risk categorization.• Preparation of documents like SOP’s, Checklists, and annexures as well BMR according to the ongoing process in cGMP plant for mammalian cell culture upstream.• Handling change control, CAPA, Deviation.

Hyderabad Area, India

Cell culture-Upstream-Worked on Commissioning and qualification of new lab and worked on Validation master plan,SLIA,FMEA. • Leading a Bioreactor team of 6 members for all day to day activities of production area.• Involved in IQ, OQ, PQ and area qualification of production area.• Worked on preparation of user requirement specification, IQ and OQ documents.• Worked various equipment's IOQ and OQ.• Worked on equipment, instruments risk categorization.• Worked Upto 750 litres bioreactor(Sartorius)• Carryout daily activity such as CIP, SIP, Vessel preparation etc.• Preparation and filtration of various media and feeds.• Vial revival and maintenance, inoculum development in shake flask and cultibag.• Preparation of documents like SOP’s, Checklists, and annexures as well BMR according to the ongoing process in cGMP plant for mammalian cell culture upstream.• Handling change control, CAPA, Deviation.• Trainer for aseptic operations like Hand disinfection, Donning of sterile gloves, Aseptic gowning, Siphon change, Surface disinfection, Bottle capping etc.• Actively involved in area and equipment qualifications.• Worked on water trials, engineering trials, Tox batches and performance validation batches.

Bangalore

• Leading a 5 member team for all day to day activities of upstream section.• Involved in IQ, OQ, PQ and area qualification of upstream section.• Worked Upto 2000 litres bioreactor(Sartorius)• Carryout daily activity such as CIP, SIP, Vessel preparation etc.• Preparation and filtration of various media and feeds.• Vial revival and maintenance, inoculum development in shake flask and cultibag.• Preparation of documents like SOP’s, Checklists, and annexures as well BMR according to the ongoing process in cGMP plant for mammalian cell culture upstream.• Monitoring of non-viable particle count as per SOP.• Handling change control, CAPA, Deviation.ACHIEVEMENTS• Successfully involved in IQ, OQ, and PQ of Bioreactors.• Successfully involved in bioreactor characterization.• Involved in process parameter optimization by doing experiments like KLA, Mixing studies, Impeller mapping.

Bengaluru, Karnataka, India

• Worked as a team member in a group of 20 for Pilot plant & production for successful commencement for various upstream batches thereby maximizing the total yield of final product.• Carryout daily activity such as CIP, SIP, Vessel preparation etc.• Preparation and filtration of various media and feeds.• Vial revival and maintenance, inoculum development in shake flask and cultibag.• Preparation of documents like SOP’s, Checklists, and annexures as well BMR according to the ongoing process in cGMP plant for mammalian cell culture upstream.• Keeping a track record of all raw material/Consumables in stores and ordering so raw materials with purchase department for the concerned raw material for the upcoming/Ongoing batches for smooth functioning of lab processes.• Interaction with other department like QA, QC, Engineering etc. for successful commencement of upstream production processes as per cGMP.• Troubleshooting of Bioreactors and other process related equipment’s to efficiently minimize errors.• Getting trained by attending various EHS and cGMP training making it sure same must be followed in the plant for required quality purpose.ACHIEVEMENTS• Successfully involved in preparation of preclinical material• Successfully installed ATF set up for developmental batches

Master Of Science -Biotechnology, Biotechnology, A

Bsc. Biotechnology, Biotechnology,Biochemistry,Genetics,Microbiology,Medical Genetics

10Th&12Th, Science