Ashutosh Kumar

Biography

  Experience Assistant Manager Company NameSyngene International Limited Dates EmployedJan 2017 – Present   Employment Duration9 mos LocationBengaluru Area, India Cell culture-Upstream Working on Commissioning and Qualification of new lab having upto 2000 litres of Bioreactor. Working 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.   Senior Officer Company NameSanofi Dates EmployedMar 2015 – Dec 2016   Employment Duration1 yr 10 mos LocationHyderabad 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. Senior Executive cell culture Company NameKemwell Biopharma Dates EmployedNov 2013 – Mar 2015   Employment Duration1 yr 5 mos LocationBangalore • 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.   scientist Cell culture Company NameBiocon Dates EmployedJun 2010 – Nov 2013   Employment Duration3 yrs 6 mos • Working 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

Research Interest

 • Strong 7.03 years of experience in MAMMALIAN CELL CULTURE. • Currently working with Syngene international from Jan 2017 to till now. • Expertise in mammalian cell culture, upstream processing and Inoculum development. • Sound knowledge of ICH, cGMP and USFDA guidelines. • Experience in handling of various type, make and volumes of BIOREACTORS : Bioengineering-Upto 50L scale Applikon-Upto 50L scale Sartorius-From 2L glass bioreactor, Cultibag, till 2000 litres SS bioreactors  Thermo Single use bioreactor upto 2000 litres Scale • Expertise in various commercial mabs from CHO cells for Bevacizumab, Trastuzumab, Adalilumumab, Itolizumab, Nimotuzumab, Eternacept, and Rituxizumab. Expertise in area and equipment qualifications IQ,OQ. Sound knowledge of handling QMS system Deviation Change control CAPA Expertise in bioreactor scale up. Technology transfer Worked on Engineering bathes,Tox batch and process validation bathes. Sound knowledge of Commissioning and Qualifications of cGMP facility.