Siram Rajendra

Biography

  Experience Assistant Manager Company NameHLL Biotech Limited Dates EmployedDec 2016 – Present   Employment Duration10 mos LocationChennai, Tamil Nadu, India Responsible for the aseptic production and fill finish for measles, Rubella and measles - Rubella combination vaccines at IVC Officer Company NameShantha Biotechnics Limited,Part of Sanofi Aventis Group Dates EmployedAug 2015 – Dec 2016   Employment Duration1 yr 5 mos LocationHyderabad Area, India Working on ROTA VIRUS and HEPATITIS-A Vaccine production. o Experienced in Large Scale production of VERO and MRC5 cells using cell factories/stacks  o Optimization of cell culture process like Cell Scale up by Passage Number, Split ratio, Seeding density, Cell Growth and Cell Expansion. o Experienced in Infection, Harvest, Clarification, distribution, Stabilization and inactivation of virus Bulk. o Cell bank preparation, cryopreservation and maintenance. o Actively involved in Aseptic process simulation (APS) using SCDM to mimic the Virus bulk Manufacturing (ROTA and HEP-A). o Preparation of Standard Operating Procedures and training employees to attain the confidence levels in handling of bulk and cultures. o Clean room and equipment validation as per ISO and EU norms. o Actively involved in initial qualification of classified areas including negative BSL-2 area. o Trend analysis for the qualification data and location identification for microbial monitoring with appropriate rational. o Developmental studies on Scale – up and handling TCFs, cell stacks. o Successful completion of Area decontamination using H2O2 (Bioquell Z2 model) as per cGMP requirements. o Perform investigation with regards to occurrences, deviation, OOS and complaint by coordinating different parties and able to close the investigation on time. o Proposed corrective/preventative action plans. Implementation and effectiveness of CAPAs. o Preparation of protocol and execution of Equipment qualification (IOQ) and Performance qualifications (PQ) for critical equipments like Aseptic connector and disconnector, Sonicator, H2O2 decontamination walk in chamber, Autoclave, Jet mixer systems, platform scale balances etc.  o Troubleshoots instrumentation within the area of expertise. o Supervision, training of staff members and man-power management. Sr.Executive cord tissue processing Company NameLifeCell International Pvt.Ltd Dates EmployedApr 2012 – Aug 2015   Employment Duration3 yrs 5 mos LocationChennai Area, India Extraction and maintenance of cell lines obtained from various stem cell origins like dental pulp, cord tissue and menstrual blood. Prepared Standard operating procedures along with Equipment operating protocols.  Well Expert working in ISO class 10000 clean rooms and in ISO class 100 LAF's with current GMP and GTP. Managing, interpretation of data and projecting to management by time to time to improve the processes. executive cord tissue Company Namelifecell int pvt ltd Dates EmployedMar 2010 – Apr 2012   Employment Duration2 yrs 2 mos LocationChennai Area, India culturing, maintenance, expansion and passaging of the human originated mesenchymal stem cells and followed by the cryo storage. executive cord tissue Company Namelifecell international pvt ltd Dates EmployedMar 2010 – Apr 2011   Employment Duration1 yr 2 mos Locationchennai Culturing, maintenance and expansion of the human originated mesenchymal stem cells followed by the passaging and cryostorage.

Research Interest

 Revival and scale up of cell lines like vero and MRC5 for viral inoculation and maintenance. Harvest of the viral culture and extraction of virus by sonication like ROTA and HEPATITIS A. Had an extensive handling of culture flasks like cs10's and cs40s Isolation and maintenance of mesenchymal stem cells from various sources like umbilical cord tissue, Dental pulp and menstural blood. Have vast experience on maintenance and scale up procedures. Expanded cells up to 10000 millions. Preparation of standard operation procedures and protocols. Worked in ISO class 10000 clean room. Have good knowledge about cGMP, cGLP and cGTP. Good knowledge on standards like ISO, WHO, AATB, ScheduleM. Been as auditee for AATB, ISO and WHO.